510(k) K011980
- Device
- ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
- Applicant
- Pace Medical
- 510(k) number
- K011980
- Product code
- DTE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-09-12
- Date received
- 2001-06-25
- Regulation
- 870.3600
- Classification name
- Pulse-Generator, Pacemaker, External
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- ROBERT C MACE
- Address
- 391 Totten Pond Rd. Waltham MA US 02451 02451
FDA Registration Numbers
- 9681449
- 3004593495
- 1721504
- 2183744
- 3012536737
- 3015225571
- 2182208
- 3018094310
- 3015309643
- 3015544746
- 3006950086
- 1028232
- 3031976597
- 3033589330
- 3035372913
- 9610139
- 3016678045
Source Documents
510(k) summary PDF not indicated by FDA
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| K042708 | ERA 3000 PACING SYSTEM ANALYZER | Biotronik, Inc. | 2004-10-20 |
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