ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33— 510(k) K083309
Substantially EquivalentZargis Medical Corp.
FDA 510(k) clearance K083309 for ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33, Substantially Equivalent on 2009-02-13. Applicant: Zargis Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Zargis Medical Corp.
- Product code
- Code DQD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Princeton, NJ, US
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