510(k) DEN070014
- Device
- MANDOMETER III
- Applicant
- Ab Mando
- 510(k) number
- DEN070014
- Product code
- OBV
- Decision
- Unknown (DENG)
- Decision date
- 2011-03-31
- Date received
- 2007-06-20
- Regulation
- 882.5060
- Classification name
- Eating Disorder Conditioning Tool
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- KIM BLOOM
- Address
- 16787 Bernardo Center Dr., Suite A-1 San Diego CA US 92128 92128
FDA Registration Numbers#
- 3009128345
Source Documents#
510(k) summary PDF not indicated by FDA