510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K943546Substantially Equivalent

Fukuda Sangyo Model Spiroanalyzer St-180

Spirosoft Northamerica, Inc., Tustin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943546 is the FDA 510(k) clearance record for FUKUDA SANGYO MODEL SPIROANALYZER ST-180, a class II device, cleared for Spirosoft Northamerica, Inc. on under FDA product code BZG (Spirometer, Diagnostic). FDA records list one 510(k) clearance for Spirosoft Northamerica, Inc. As of , FDA records show no recalls naming K943546.

Clearance record

Decision date
Received
(217 days to decision)
Product code
BZG Spirometer, Diagnostic
Regulation
21 CFR 868.1840
Device class
Class II
Review panel
Anesthesiology
Applicant
Spirosoft Northamerica, Inc. 2522 Chambers Rd., Tustin CA
510(k) summary
Statement
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