510(k) K022360
- Device
- 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.
- Applicant
- Biotronik, Inc.
- 510(k) number
- K022360
- Product code
- DTA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-01-27
- Date received
- 2002-07-19
- Regulation
- 870.3720
- Classification name
- Tester, Pacemaker Electrode Function
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jon Brumbaugh
- Address
- 6024 Jean Rd. Lake Oswego OR US 97035 97035
FDA Registration Numbers#
- 2135338
- 2017865
- 3009265194
- 9610139
- 3017636737
- 1047843
- 2182208
- 1028232
- 9681449
- 1056553
Source Documents#
Other 510(k) Records For Product Code DTA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K163008 | CareLink SmartSync Device Manager - Pacing System Analyzer | Medtronic, Inc. | 2017-02-28 |
| K101982 | MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 | St Jude Medical, Crmd | 2010-12-21 |
| K073230 | MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS | Biotronik, Inc. | 2007-12-20 |
| K050884 | ADAPTER CABLE | Remington Medical, Inc. | 2005-05-19 |
| K033613 | MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER | Biotronik, Inc. | 2003-12-08 |
| K933069 | MODEL EP-2 CLINICAL STIMULATOR | Ep Medical, Inc. | 1993-10-21 |
| K812104 | SIEMENS-ELEMA PSA 376 | Siemens Corp. | 1981-12-02 |
| K791380 | VA 1000 | Vitatron Medical BV | 1979-09-19 |
| K790503 | CARDIOTEST 2200 | Cardiac Pacemakers, Inc. | 1979-05-17 |