Electrocardiographic Patient Cables
FDA 510(k) K771027 · Tronomed, Inc.
510(k) numberK771027
Submission
- Device name
- Electrocardiographic Patient Cables
- Applicant
- Tronomed, Inc.
Mchenry, IL, US - Received
- June 8, 1977
- Decision date
- July 5, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K952659 | Tronomate Patient Cable & Leadwire SystemDSA · Traditional | 01/11/1996SE |
| K853303 | Lifelinc LeadwireBZQ · Traditional | 09/18/1985SE |
| K853452 | Life Linc Patient CableBZQ · Traditional | 09/10/1985SE |
| K841092 | High Pressure Flex. Connecting TubingDXT · Traditional | 07/24/1985SE |
| K792128 | Sterile Extension Tubes Indiv. Pkg.FMG · Traditional | 01/16/1980SE |
| K792127 | Plas. Stck. W/Extension Tube/SterileFMG · Traditional | 01/16/1980SE |
| K792126 | 3&4 Way Plastic Sterile Stpcks. Pkg.FMG · Traditional | 01/16/1980SE |
| K792125 | 3&4 Way Plastic Stopcocks, NonsterileFMG · Traditional | 01/16/1980SE |
| K792124 | Tandem Assembled 3&4 Way StopcocksFMG · Traditional | 01/16/1980SE |
| K771645 | Electrocardiographic Cablhs & Lead WireDSA · Traditional | 10/18/1977SE |
Questions and answers
When was Electrocardiographic Patient Cables cleared by the FDA?
Electrocardiographic Patient Cables (K771027) received a 510(k) decision of Substantially Equivalent on July 5, 1977, 27 days after the submission was received.
What is the product code of K771027?
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.