510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991212Substantially Equivalent

Modification to Truzone Peak Flow Meter

Monaghan Medical Corp., Plattsburgh NY / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K991212 is the FDA 510(k) clearance record for MODIFICATION TO TRUZONE PEAK FLOW METER, a class II device, cleared for Monaghan Medical Corp. on under FDA product code BZH (Meter, Peak Flow, Spirometry). FDA records list 35 510(k) clearances for Monaghan Medical Corp., from to . As of , FDA records show no recalls naming K991212.

Clearance record

Decision date
Received
(83 days to decision)
Product code
BZH Meter, Peak Flow, Spirometry
Regulation
21 CFR 868.1860
Device class
Class II
Review panel
Anesthesiology
Applicant
Monaghan Medical Corp. 5 Latour Ave., Suite 1600, Plattsburgh NY
510(k) summary
Statement
Third party review
No

Clearances, product code BZH

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