510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230501Substantially Equivalent

Spirobank Oxi

Mir Medical International Research USA, New Berlin WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230501 is the FDA 510(k) clearance record for Spirobank Oxi, a class II device, cleared for Mir Medical International Research USA on under FDA product code BZG (Spirometer, Diagnostic). FDA records list one 510(k) clearance for Mir Medical International Research USA. As of , FDA records show no recalls naming K230501.

Clearance record

Decision date
Received
(294 days to decision)
Product code
BZG Spirometer, Diagnostic
Regulation
21 CFR 868.1840
Device class
Class II
Review panel
Anesthesiology
Applicant
Mir Medical International Research USA 5462 S. Westridge Dr., New Berlin WI
510(k) summary
Summary PDF
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