Arbo VS Monitor Cable & Leadwire System Arbo Shielded Safety Cable & Lead Wire
FDA 510(k) K940322 · Arbo Medical, Inc.
510(k) numberK940322
Submission
- Device name
- Arbo VS Monitor Cable & Leadwire System Arbo Shielded Safety Cable & Lead Wire
- Applicant
- Arbo Medical, Inc.
West Cadwell, NJ, US - Received
- January 24, 1994
- Decision date
- November 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DSA – Cable, Transducer And Electrode, Patient, (Including Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2900
- Specialty
- Cardiovascular
Other 510(k)s with product code DSA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254114 | Baylis Connector CableDSA · Special | Baylis Medical Technologies, Inc. | 01/18/2026SE |
| K252827 | IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott…DSA · Traditional | Drägerwerk AG & Co. KGaA | 12/01/2025SE |
| K251669 | IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger…DSA · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 09/30/2025SE |
| K242986 | SpO2 Extension CableDSA · Special | Beijing Rongrui-Century Science & Technology… | 05/02/2025SE |
| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171…DSA · Traditional | Philips Medizin Systeme Böblingen GmbH | 01/17/2025SE |
| K240087 | RT Carbon ECG LeadsDSA · Traditional | Ivy Biomedical Systems, Inc. | 09/13/2024SE |
| K240377 | LIFEPAK® ECG CablesDSA · Traditional | Stryker Physio-Control | 05/07/2024SE |
| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…DSA · Traditional | Physio-Control, Inc. | 04/30/2024SE |
| K222712 | Fogg System Patient Monitoring CablesDSA · Traditional | Fogg System Company, Inc. | 11/22/2023SE |
| K230571 | RFP-100A Connector Cable (Single Use)DSA · Traditional | Baylis Medical Technologies, Inc. | 05/30/2023SE |
More from Baylis Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940323 | Arbo Diagnostic ECG Patient Cables & Leadwires Arbo Shielded Multi-Lead Cable & Lead…DSA · Traditional | 04/12/1995SE |
| K935437 | Arbo H85V/H87V/H27V Dispos Monit ElectrodesDRX · Traditional | 04/06/1995SE |
| K942905 | Disposable Temperature Probe CoverFMT · Traditional | 02/27/1995SE |
| K940302 | Arbo Monitring Safety Cable & Lead Wire Systems/Arbo Unsheilded Safety Cable & Lead SystemDSA · Traditional | 11/30/1994SE |
| K935246 | Arbo H49P, H59P Disposable Monitoring ElectrodesDRX · Traditional | 11/16/1994SE |
| K935429 | Arbo H90, H91, H135 Disposable Monitoring ElectrodesDRX · Traditional | 11/01/1994SE |
| K935281 | Arbo H87P, H85P, H27P Disposable Monitoring ElectrodesDRX · Traditional | 09/06/1994SE |
| K905545 | Ultrasound Transmission GelJOT · Traditional | 03/29/1991SE |
| K902788 | Clem TMFIB · Traditional | 09/12/1990SE |
| K901816 | Pressure Tubing and AccessoriesCAH · Traditional | 07/12/1990SE |
Questions and answers
When was Arbo VS Monitor Cable & Leadwire System Arbo Shielded Safety Cable & Lead Wire cleared by the FDA?
Arbo VS Monitor Cable & Leadwire System Arbo Shielded Safety Cable & Lead Wire (K940322) received a 510(k) decision of Substantially Equivalent on November 28, 1994, 308 days after the submission was received.
What is the product code of K940322?
The FDA product code is DSA – Cable, Transducer And Electrode, Patient, (Including Connector), a Class II (moderate risk) device regulated under 21 CFR 870.2900.