External Pulse Generator for Temp. Stim
FDA 510(k) K831768 · Oscor, Inc.
510(k) numberK831768
Submission
- Device name
- External Pulse Generator for Temp. Stim
- Applicant
- Oscor, Inc.
Palm Harbor, FL, US - Received
- June 1, 1983
- Decision date
- December 16, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTE – Pulse-Generator, Pacemaker, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3600
- Specialty
- Cardiovascular
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|---|---|---|---|
| K241781 | Solo Pace ControlDTE · Traditional | Solo Pace, Inc. | 01/10/2025SE |
| K232721 | Lifetech Cardio Temporary PacemakerDTE · Special | Shenzhen Lifetech Cardio Medical Electronics… | 01/07/2024SE |
| K201011 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 05/13/2020SE |
| K190825 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 04/30/2019SE |
| K182839 | Lifetech Cardio Model 8301 Temporary PacemakerDTE · Traditional | Shenzhen Lifetech Cardio Medical Electronics… | 02/28/2019SE |
| K181973 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 08/21/2018SE |
| K180873 | Medtronic Model 53401 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 04/19/2018SE |
| K162054 | Medtronic Temporary External Pacemaker 53401DTE · Traditional | Medtronic, Inc. | 10/18/2016SE |
| K162550 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 10/12/2016SE |
| K150246 | Medtronic Model 5392 External Pulse Generator (EPG)DTE · Special | Medtronic, Inc. | 02/18/2015SE |
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Questions and answers
When was External Pulse Generator for Temp. Stim cleared by the FDA?
External Pulse Generator for Temp. Stim (K831768) received a 510(k) decision of Substantially Equivalent on December 16, 1983, 198 days after the submission was received.
What is the product code of K831768?
The FDA product code is DTE – Pulse-Generator, Pacemaker, External, a Class II (moderate risk) device regulated under 21 CFR 870.3600.