510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN070014Unknown

Mandometer III

AB Mando, San Diego CA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN070014 is the FDA 510(k) clearance record for MANDOMETER III, a class II device, cleared for Ab Mando on under FDA product code OBV (Eating Disorder Conditioning Tool). FDA's definition for product code OBV reads: "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". FDA records list one 510(k) clearance for Ab Mando. As of , FDA records show no recalls naming DEN070014.

Clearance record

Decision date
Received
(1,380 days to decision)
Product code
OBV Eating Disorder Conditioning Tool
Regulation
21 CFR 882.5060
Device class
Class II
Review panel
Neurology
Applicant
Ab Mando 16787 Bernardo Center Dr.,, San Diego CA
Third party review
No

Clearances, product code OBV

Trailing 12 months

FDA records hold no clearances under product code OBV in the trailing twelve months.

FDA records show no clearances under product code OBV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OBV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260