MINIMAP MODEL 810
FDA 510(k) clearance K771981 · decided 1978-01-24
Clearance details
- K-number
- K771981
- Device name
- MINIMAP MODEL 810
- Applicant
- Applied Medical Research
- Decision
- Substantially Equivalent
- Date received
- 1977-10-18
- Decision date
- 1978-01-24
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- DSK
- Device class
- 2
- Regulation number
- 870.1110
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.