COBE ICU CONVERSION KIT
FDA 510(k) clearance K902631 · decided 1990-12-17
Clearance details
- K-number
- K902631
- Device name
- COBE ICU CONVERSION KIT
- Applicant
- Cobe Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-06-14
- Decision date
- 1990-12-17
- Days to decision
- 186 days
- Clearance type
- Traditional
- Product code
- DTN
- Device class
- 2
- Regulation number
- 870.4400
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Lakewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.