NEW COBE SATURATION/HEMATOCRIT MONITOR— 510(k) K904336
Substantially EquivalentCobe Laboratories, Inc.
FDA 510(k) clearance K904336 for NEW COBE SATURATION/HEMATOCRIT MONITOR, Substantially Equivalent on 1990-12-27. Applicant: Cobe Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Cobe Laboratories, Inc.
- Product code
- Code GKF
- Device class
- Class 2
- Regulation
- 21 CFR 864.5600
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arvada, CO, US
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