510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K900331Substantially Equivalent

Tuba Tm (Transit-Time Ultrasonic Breath Analyzer)

Ghg Medizin-Elektronik AG, Zurich Z H, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900331 is the FDA 510(k) clearance record for TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER), a class II device, cleared for Ghg Medizin-Elektronik AG on under FDA product code BZG (Spirometer, Diagnostic). FDA records list one 510(k) clearance for Ghg Medizin-Elektronik AG. As of , FDA records show no recalls naming K900331.

Clearance record

Decision date
Received
(224 days to decision)
Product code
BZG Spirometer, Diagnostic
Regulation
21 CFR 868.1840
Device class
Class II
Review panel
Anesthesiology
Applicant
Ghg Medizin-Elektronik AG Mainaustrasse 15, Zurich Z H, CH
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