Propaq ECG Telemetry Option
FDA 510(k) K934711 · Protocol Systems, Inc.
510(k) numberK934711
Submission
- Device name
- Propaq ECG Telemetry Option
- Applicant
- Protocol Systems, Inc.
Beaverton, OR, US - Received
- October 1, 1993
- Decision date
- September 1, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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| K914838 | Propaq 102,104,106,102EL,104EL,&106ELMHX · Traditional | 01/10/1992SE |
| K913193 | Model 100 Central StationDQK · Traditional | 10/16/1991SE |
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Questions and answers
When was Propaq ECG Telemetry Option cleared by the FDA?
Propaq ECG Telemetry Option (K934711) received a 510(k) decision of Substantially Equivalent on September 1, 1994, 335 days after the submission was received.
What is the product code of K934711?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.