ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28
FDA 510(k) clearance K060197 · decided 2006-03-29
Clearance details
- K-number
- K060197
- Device name
- ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28
- Applicant
- Zargis Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-01-26
- Decision date
- 2006-03-29
- Days to decision
- 62 days
- Clearance type
- Special
- Product code
- DQD
- Device class
- 2
- Regulation number
- 870.1875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.