MANDOMETER III
FDA 510(k) clearance DEN070014 · decided 2011-03-31
Clearance details
- K-number
- DEN070014
- Device name
- MANDOMETER III
- Applicant
- Ab Mando
- Decision
- Unknown
- Date received
- 2007-06-20
- Decision date
- 2011-03-31
- Days to decision
- 1380 days
- Clearance type
- Post-NSE
- Product code
- OBV
- Device class
- 2
- Regulation number
- 882.5060
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.