FLOSCOPE MICRODOP
FDA 510(k) clearance K910441 · decided 1991-03-21
Clearance details
- K-number
- K910441
- Device name
- FLOSCOPE MICRODOP
- Applicant
- Advance Medical Device, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-01-31
- Decision date
- 1991-03-21
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- DPT
- Device class
- 2
- Regulation number
- 870.2120
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Berlin, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.