Siemens-Elema Psa 376
FDA 510(k) K812104 · Siemens Corp.
510(k) numberK812104
Submission
- Device name
- Siemens-Elema Psa 376
- Applicant
- Siemens Corp.
Mchenry, IL, US - Received
- July 24, 1981
- Decision date
- December 2, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTA – Tester, Pacemaker Electrode Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3720
- Specialty
- Cardiovascular
Other 510(k)s with product code DTA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K163008 | CareLink SmartSync Device Manager - Pacing System AnalyzerDTA · Traditional | Medtronic, Inc. | 02/28/2017SE |
| K101982 | Merlin Psa Patient Cable Ex 3150, Cable Adapter EX3170, M Adapter EX3180DTA · Traditional | St Jude Medical, Crmd | 12/21/2010SE |
| K073230 | Models Era 300 and 3105 Pacing System AnalyzersDTA · Special | Biotronik, Inc. | 12/20/2007SE |
| K050884 | Adapter CableDTA · Traditional | Remington Medical, Inc. | 05/19/2005SE |
| K033613 | Modification to Era 300 Dual Chamber Pacing System AnalyzerDTA · Special | Biotronik, Inc. | 12/08/2003SE |
| K022360 | Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000…DTA · Traditional | Biotronik, Inc. | 01/27/2003SE |
| K933069 | Model EP-2 Clinical StimulatorDTA · Traditional | Ep Medical, Inc. | 10/21/1993SE |
| K791380 | Va 1000DTA · Traditional | Vitatron Medical BV | 09/19/1979SE |
| K790503 | Cardiotest 2200DTA · Traditional | Cardiac Pacemakers, Inc. | 05/17/1979SE |
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| K103360 | Dimension Vista Digitoxin Calibrator - DGTX CalJIT · Traditional | 12/17/2010SE |
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Questions and answers
When was Siemens-Elema Psa 376 cleared by the FDA?
Siemens-Elema Psa 376 (K812104) received a 510(k) decision of Substantially Equivalent on December 2, 1981, 131 days after the submission was received.
What is the product code of K812104?
The FDA product code is DTA – Tester, Pacemaker Electrode Function, a Class II (moderate risk) device regulated under 21 CFR 870.3720.