MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
FDA 510(k) clearance K033613 · decided 2003-12-08
Clearance details
- K-number
- K033613
- Device name
- MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
- Applicant
- Biotronik, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-11-17
- Decision date
- 2003-12-08
- Days to decision
- 21 days
- Clearance type
- Special
- Product code
- DTA
- Device class
- 2
- Regulation number
- 870.3720
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lake Oswego, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CareLink SmartSync Device Manager - Pacing System Analyzer (K163008) | Medtronic, Inc. | 2017-02-28 |
| MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 (K101982) | St Jude Medical, Crmd | 2010-12-21 |
| MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS (K073230) | Biotronik, Inc. | 2007-12-20 |
| ADAPTER CABLE (K050884) | Remington Medical, Inc. | 2005-05-19 |
| ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. (K022360) | Biotronik, Inc. | 2003-01-27 |
| MODEL EP-2 CLINICAL STIMULATOR (K933069) | Ep Medical, Inc. | 1993-10-21 |
| SIEMENS-ELEMA PSA 376 (K812104) | Siemens Corp. | 1981-12-02 |
| VA 1000 (K791380) | Vitatron Medical BV | 1979-09-19 |
| CARDIOTEST 2200 (K790503) | Cardiac Pacemakers, Inc. | 1979-05-17 |
Recalls involving this device
No recalls on record reference this clearance.