510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K080299Substantially Equivalent

Respifit S, Model Rs-Lr1001004

Eumedics Medizintechnik und Marketing GmbH, Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080299 is the FDA 510(k) clearance record for RESPIFIT S, MODEL RS-LR1001004, a class II device, cleared for Eumedics Medizintechnik Und Marketing GmbH on under FDA product code BWF (Spirometer, Therapeutic (Incentive)). FDA records list one 510(k) clearance for Eumedics Medizintechnik Und Marketing GmbH. As of , FDA records show no recalls naming K080299.

Clearance record

Decision date
Received
(343 days to decision)
Product code
BWF Spirometer, Therapeutic (Incentive)
Regulation
21 CFR 868.5690
Device class
Class II
Review panel
Anesthesiology
Applicant
Eumedics Medizintechnik Und Marketing GmbH 1341 W Fullerton, Chicago IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BWF

Trailing 12 months

FDA records hold no clearances under product code BWF in the trailing twelve months.

FDA records show no clearances under product code BWF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BWF, 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 20260
October 20260