The following data is part of a De Novo classification by Ab Mando with the FDA for Mandometer Iii.
| DeNovo ID | DEN070014 |
| Device Name: | MANDOMETER III |
| Classification | Eating Disorder Conditioning Tool |
| Applicant | AB MANDO 16787 Bernardo Center Drive suite A-1 San Diego, CA 92128 |
| Contact | Kim Bloom |
| Product Code | OBV |
| CFR Regulation Number | 882.5060 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K063817 |
| Review Advisory Board | Neurology |
| Classification Advisory | Neurology |
| Type | Post-NSE |
| Date Received | 2007-06-20 |
| Decision Date | 2011-03-31 |
| Reclassification Order: | Reclassification Order |