OMEGA CARES SYSTEM
FDA 510(k) clearance K945068 · decided 1996-01-25
Clearance details
- K-number
- K945068
- Device name
- OMEGA CARES SYSTEM
- Applicant
- J-F Medical Systems Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-14
- Decision date
- 1996-01-25
- Days to decision
- 468 days
- Clearance type
- Traditional
- Product code
- DQK
- Device class
- 2
- Regulation number
- 870.1425
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Carrollton, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.