Models Era 300 and 3105 Pacing System Analyzers
FDA 510(k) K073230 · Biotronik, Inc.
510(k) numberK073230
Submission
- Device name
- Models Era 300 and 3105 Pacing System Analyzers
- Applicant
- Biotronik, Inc.
Lake Oswego, OR, US - Received
- November 15, 2007
- Decision date
- December 20, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K812104 | Siemens-Elema Psa 376DTA · Traditional | Siemens Corp. | 12/02/1981SE |
| K791380 | Va 1000DTA · Traditional | Vitatron Medical BV | 09/19/1979SE |
| K790503 | Cardiotest 2200DTA · Traditional | Cardiac Pacemakers, Inc. | 05/17/1979SE |
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Questions and answers
When was Models Era 300 and 3105 Pacing System Analyzers cleared by the FDA?
Models Era 300 and 3105 Pacing System Analyzers (K073230) received a 510(k) decision of Substantially Equivalent on December 20, 2007, 35 days after the submission was received.
What is the product code of K073230?
The FDA product code is DTA – Tester, Pacemaker Electrode Function, a Class II (moderate risk) device regulated under 21 CFR 870.3720.