POINT-OF-CARE BLOOD GAS MONITOR SYSTEM— 510(k) K961790
Substantially EquivalentOptical Sensors, Inc.
FDA 510(k) clearance K961790 for POINT-OF-CARE BLOOD GAS MONITOR SYSTEM, Substantially Equivalent on 1997-04-09. Applicant: Optical Sensors, Inc.. Device class: 2.
Clearance details
- Applicant
- Optical Sensors, Inc.
- Product code
- Code CCC
- Device class
- Class 2
- Regulation
- 21 CFR 868.1150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
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