CARDIOLAB AMPLIFIER MODULE (CAM)— 510(k) K910307
Substantially EquivalentPrucka Engineering, Inc.
FDA 510(k) clearance K910307 for CARDIOLAB AMPLIFIER MODULE (CAM), Substantially Equivalent on 1991-04-12. Applicant: Prucka Engineering, Inc.. Device class: 2.
Clearance details
- Applicant
- Prucka Engineering, Inc.
- Product code
- Code DRR
- Device class
- Class 2
- Regulation
- 21 CFR 870.2050
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
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