510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854403Substantially Equivalent

Model 2120 Spiroscreen

Gould, Inc., Dayton OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854403 is the FDA 510(k) clearance record for MODEL 2120 SPIROSCREEN, a class II device, cleared for Gould, Inc. on under FDA product code BZG (Spirometer, Diagnostic). FDA records list 3 510(k) clearances for Gould, Inc., from to . As of , FDA records show no recalls naming K854403.

Clearance record

Decision date
Received
(75 days to decision)
Product code
BZG Spirometer, Diagnostic
Regulation
21 CFR 868.1840
Device class
Class II
Review panel
Anesthesiology
Applicant
Gould, Inc. 805 Liberty Ln., Dayton OH
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