Arbo H87P, H85P, H27P Disposable Monitoring Electrodes
FDA 510(k) K935281 · Arbo Medical, Inc.
510(k) numberK935281
Submission
- Device name
- Arbo H87P, H85P, H27P Disposable Monitoring Electrodes
- Applicant
- Arbo Medical, Inc.
Stratford, CT, US - Received
- November 3, 1993
- Decision date
- September 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
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More from Suzuken Co., Ltd.
| 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 |
| K940322 | Arbo VS Monitor Cable & Leadwire System Arbo Shielded Safety Cable & Lead WireDSA · Traditional | 11/28/1994SE |
| K935246 | Arbo H49P, H59P Disposable Monitoring ElectrodesDRX · Traditional | 11/16/1994SE |
| K935429 | Arbo H90, H91, H135 Disposable Monitoring ElectrodesDRX · Traditional | 11/01/1994SE |
| 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 H87P, H85P, H27P Disposable Monitoring Electrodes cleared by the FDA?
Arbo H87P, H85P, H27P Disposable Monitoring Electrodes (K935281) received a 510(k) decision of Substantially Equivalent on September 6, 1994, 307 days after the submission was received.
What is the product code of K935281?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.