Tuba TM (Transit-Time Ultrasonic Breath Analyzer)

FDA 510(k) K900331 · Ghg Medizin-Elektronik AG

Substantially Equivalent

510(k) numberK900331

Submission

Device name
Tuba TM (Transit-Time Ultrasonic Breath Analyzer)
Applicant
Ghg Medizin-Elektronik AG
Zurich Z H, CH
Received
January 23, 1990
Decision date
September 4, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BZG – Spirometer, Diagnostic
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1840
Specialty
Anesthesiology

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K231416Air Next (NVD-02)BZG · Traditional Nuvoair AB01/18/2024SE
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K222443Air Smart Extra SpirometerBZG · Traditional Feellife Health, Inc.08/09/2023SE
K213754SpiroHome Personal, SpiroHome ClinicBZG · Traditional Inofab Saglik Teknolojileri A.S06/12/2023SE
K213872ComPAS2BZG · Traditional Morgan Scientific, Inc.07/15/2022SE
K212938Vitalograph Model 6000 AlphaBZG · Traditional Vitalograph Ireland, Ltd.01/26/2022SE

Questions and answers

When was Tuba TM (Transit-Time Ultrasonic Breath Analyzer) cleared by the FDA?

Tuba TM (Transit-Time Ultrasonic Breath Analyzer) (K900331) received a 510(k) decision of Substantially Equivalent on September 4, 1990, 224 days after the submission was received.

What is the product code of K900331?

The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.