510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982675Substantially Equivalent

Airwatch II Zoneless

Enact Health Management Systems, Mountain View CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982675 is the FDA 510(k) clearance record for AIRWATCH II ZONELESS, a class II device, cleared for Enact Health Management Systems on under FDA product code BZH (Meter, Peak Flow, Spirometry). FDA records list 3 510(k) clearances for Enact Health Management Systems, from to . As of , FDA records show no recalls naming K982675.

Clearance record

Decision date
Received
(90 days to decision)
Product code
BZH Meter, Peak Flow, Spirometry
Regulation
21 CFR 868.1860
Device class
Class II
Review panel
Anesthesiology
Applicant
Enact Health Management Systems 1975 El Camino Real W., #306, Mountain View CA
510(k) summary
Summary
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