510(k) K980937
- Device
- NICORE MODEL ESP -1
- Applicant
- NICORE EQUIPMENT & LEASING, INC.
- 510(k) number
- K980937
- Product code
- DRN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-09-15
- Date received
- 1998-03-12
- Regulation
- 870.5225
- Classification name
- Device, Counter-pulsating, External
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- MICHAEL G FARROW
- Address
- 1625 K St. NW Suite 1000 Washington DC US 20006 20006
FDA Registration Numbers
- 3010135889
- 2435300
- 3010564728
- 3028606342
- 1319639
- 3010145926
- 3002806999
- 3012470925
- 3017791225
Source Documents
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| K042413 | ACS MODEL NCP-2 | Applied Cardiac Systems | 2004-12-09 |
| K033617 | EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY | Vasomedical, Inc. | 2004-03-01 |
| K033657 | MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V | Living Data Technologies Corporation | 2003-12-19 |
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Legacy Summary
summary
FDA Review
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