NEW COBE SATURATION/HEMATOCRIT MONITOR
FDA 510(k) clearance K904336 · decided 1990-12-27
Clearance details
- K-number
- K904336
- Device name
- NEW COBE SATURATION/HEMATOCRIT MONITOR
- Applicant
- Cobe Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-09-20
- Decision date
- 1990-12-27
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- GKF
- Device class
- 2
- Regulation number
- 864.5600
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Arvada, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cobe Laboratories
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.