SERVO-PAK MOLEL 0030— 510(k) K771510
Substantially EquivalentIsothermal Systems, Inc.
FDA 510(k) clearance K771510 for SERVO-PAK MOLEL 0030, Substantially Equivalent on 1977-08-16. Applicant: Isothermal Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Isothermal Systems, Inc.
- Product code
- Code BXA
- Device class
- Class 1
- Regulation
- 21 CFR 868.1975
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code BXA
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