510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K862958Substantially Equivalent

Amr Research Tonometer

Associated Medical Representatives, Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862958 is the FDA 510(k) clearance record for AMR RESEARCH TONOMETER, a class I device, cleared for Associated Medical Representatives on under FDA product code LCH (Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical). FDA records list one 510(k) clearance for Associated Medical Representatives. As of , FDA records show no recalls naming K862958.

Clearance record

Decision date
Received
(111 days to decision)
Product code
LCH Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Associated Medical Representatives 890 W. 70th Pl., Denver CO
Third party review
No

Clearances, product code LCH

Trailing 12 months

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

FDA records show no clearances under product code LCH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCH, 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