510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K831237Substantially Equivalent

Spiromed Respirometer

Draeger, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831237 is the FDA 510(k) clearance record for SPIROMED RESPIROMETER, a class II device, cleared for Draeger Medical, Inc. on under FDA product code BZK (Spirometer, Monitoring (W/Wo Alarm)). FDA records list 84 510(k) clearances for DRAEGER, INC., from to . As of , FDA records show no recalls naming K831237.

Clearance record

Decision date
Received
(24 days to decision)
Product code
BZK Spirometer, Monitoring (W/Wo Alarm)
Regulation
21 CFR 868.1850
Device class
Class II
Review panel
Anesthesiology
Applicant
Draeger Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BZK

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