510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K954759Substantially Equivalent

Flowmate Lte

Spirometrics Medical Equipment Co., Auburn ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954759 is the FDA 510(k) clearance record for FLOWMATE LTE, a class II device, cleared for Spirometrics Medical Equipment Co. on under FDA product code BZG (Spirometer, Diagnostic). FDA records list 3 510(k) clearances for Spirometrics Medical Equipment Co., from to . As of , FDA records show no recalls naming K954759.

Clearance record

Decision date
Received
(178 days to decision)
Product code
BZG Spirometer, Diagnostic
Regulation
21 CFR 868.1840
Device class
Class II
Review panel
Anesthesiology
Applicant
Spirometrics Medical Equipment Co. 415 Rodman Rd., Auburn ME
510(k) summary
Summary
Third party review
No

Clearances, product code BZG

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