510(k) DEN070014
DEN070014 is an FDA 510(k) premarket notification submitted by Ab Mando for the device "MANDOMETER III". The FDA issued a decision of De Novo Granted on March 31, 2011. The device falls under product code OBV (Eating Disorder Conditioning Tool), a Class II device regulated under 21 CFR 882.5060.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 31, 2011
- Date Received
- June 20, 2007
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Eating Disorder Conditioning Tool
- Device Class
- Class II
- Regulation Number
- 882.5060
- Review Panel
- NE
- Submission Type
A conditioning tool for eating disorders is a medical device that non-invasively measures the mass of food eaten during a meal and provides feedback in the form of eating rate, patient satiety, and eating pattern information to the patient.