STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR— 510(k) K924354
Substantially EquivalentSorin Biomedica, Fiat, USA, Inc.
FDA 510(k) clearance K924354 for STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR, Substantially Equivalent on 1993-02-18. Applicant: Sorin Biomedica, Fiat, USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Sorin Biomedica, Fiat, USA, Inc.
- Product code
- Code DTW
- Device class
- Class 2
- Regulation
- 21 CFR 870.4340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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