BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS— 510(k) K901548
Substantially EquivalentShiley, Inc.
FDA 510(k) clearance K901548 for BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS, Substantially Equivalent on 1991-01-14. Applicant: Shiley, Inc.. Device class: 2.
Clearance details
- Applicant
- Shiley, 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
- Irvine, CA, US
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