Pacer Monitor, Pulse Width
FDA 510(k) K772178 · Survival Technology, Inc.
510(k) numberK772178
Submission
- Device name
- Pacer Monitor, Pulse Width
- Applicant
- Survival Technology, Inc.
Mchenry, IL, US - Received
- November 22, 1977
- Decision date
- December 8, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
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More from AliveCor, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925535 | Cardiobeeper(R) Cb-IiaDXH · Traditional | 01/28/1993SE |
| K894799 | Cardiobeeper Memory Monitor CB 600 SeriesDXH · Traditional | 10/03/1989SE |
| K890461 | Cardiobeeper IVDXH · Traditional | 02/23/1989SE |
| K883843 | Cardiobeeper IIDXH · Traditional | 11/09/1988SE |
| K883614 | Cytoguard(R)FMF · Traditional | 09/15/1988SE |
| K880300 | Cardiobeeper(R) IIIDXH · Traditional | 05/12/1988SE |
| K844966 | Cardiobeeper Profile MonitorDXH · Traditional | 02/08/1985SE |
| K822093 | Stat-ScanDXG · Traditional | 09/21/1982SE |
| K813101 | Cardiobeeper Memory MonitorDXY · Traditional | 11/27/1981SE |
Questions and answers
When was Pacer Monitor, Pulse Width cleared by the FDA?
Pacer Monitor, Pulse Width (K772178) received a 510(k) decision of Substantially Equivalent on December 8, 1977, 16 days after the submission was received.
What is the product code of K772178?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.