HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL
FDA 510(k) clearance DEN050007 · decided 2006-03-27
Clearance details
- K-number
- DEN050007
- Device name
- HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL
- Applicant
- Fmg Innovations, Inc.
- Decision
- Unknown
- Date received
- 2005-06-20
- Decision date
- 2006-03-27
- Days to decision
- 280 days
- Clearance type
- Post-NSE
- Product code
- NRK
- Device class
- 2
- Regulation number
- 874.1600
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.