510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K861771Substantially Equivalent

Meta - Health Model Mtg III

Meta Health, Inc., Richmond VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861771 is the FDA 510(k) clearance record for META - HEALTH MODEL MTG III, a class II device, cleared for Meta Health, Inc. on under FDA product code FLL (Continuous Measurement Thermometer). FDA's definition for product code FLL reads: "A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt...". FDA records list one 510(k) clearance for Meta Health, Inc. As of , FDA records show no recalls naming K861771.

Clearance record

Decision date
Received
(54 days to decision)
Product code
FLL Continuous Measurement Thermometer
Regulation
21 CFR 880.2910
Device class
Class II
Review panel
General Hospital
Applicant
Meta Health, Inc. 5501 Patterson Ave., Richmond VA
Third party review
No

Clearances, product code FLL

Trailing 12 months
2 clearances under product code FLL in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FLL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260