510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934502Substantially Equivalent

Flow Spirometer

Healthdyne, Inc., Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934502 is the FDA 510(k) clearance record for FLOW SPIROMETER, a class II device, cleared for Healthdyne, Inc. on under FDA product code BZH (Meter, Peak Flow, Spirometry). FDA records list 35 510(k) clearances for Healthdyne, Inc., from to . As of , FDA records show no recalls naming K934502.

Clearance record

Decision date
Received
(202 days to decision)
Product code
BZH Meter, Peak Flow, Spirometry
Regulation
21 CFR 868.1860
Device class
Class II
Review panel
Anesthesiology
Applicant
Healthdyne, Inc. 1850 Pkwy. Pl., 12th Floor, Marietta GA
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