510(k) K042708
- Device
- ERA 3000 PACING SYSTEM ANALYZER
- Applicant
- BIOTRONIK, INC.
- 510(k) number
- K042708
- Product code
- DTE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-10-20
- Date received
- 2004-09-30
- Regulation
- 870.3600
- Classification name
- Pulse-generator, Pacemaker, External
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Jon Brumbaugh
- Address
- 6024 Jean Rd. Lake Oswego OR US 97035 97035
FDA Registration Numbers#
- 2182208
- 3006950086
- 3015544746
- 9610139
- 1028232
- 3015225571
- 9681449
- 1721504
- 2183744
- 3016678045
- 3012536737
- 3033589330
- 3004593495
- 3031976597
- 3035372913
- 3018094310
- 3015309643
Source Documents#
Other 510(k) Records For Product Code DTE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241781 | Solo Pace Control | Solo Pace, Inc. | 2025-01-10 |
| K232721 | Lifetech Cardio Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2024-01-07 |
| K201011 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2020-05-13 |
| K190825 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2019-04-30 |
| K182839 | Lifetech Cardio Model 8301 Temporary Pacemaker | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. | 2019-02-28 |
| K181973 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2018-08-21 |
| K180873 | Medtronic Model 53401 External Pulse Generator (EPG) | Medtronic, Inc. | 2018-04-19 |
| K162054 | Medtronic Temporary External Pacemaker 53401 | Medtronic, Inc. | 2016-10-18 |
| K162550 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2016-10-12 |
| K150246 | Medtronic Model 5392 External Pulse Generator (EPG) | Medtronic, Inc. | 2015-02-18 |
| K132924 | MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) | Medtronic, Inc. | 2013-10-31 |
| K123916 | PSA SERIES | Osypka Medical, Inc. | 2013-04-09 |
| K033130 | PACE 101/PACE 101H, MODEL 3077 SSI TEMPORARY PULSE GENERATOR | Osypka Medical, Inc. | 2003-10-31 |
| K023080 | GALIX PACESTAR | Galix Biomedical Instrumentation, Inc. | 2003-06-11 |
| K022939 | OSCOR PACE 101/101H AND ACCESSORIES, ST.JUDE MEDICAL MODEL 3077 AND ACCESSORIES,CARDIOTRONIC PACE 101 AND ACCESSORIES | Osypka Medical, Inc. | 2002-10-03 |
Legacy Summary#
summary
FDA Review#
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