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FDA 510(k)

TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)

K-Number: K900331 · 1990-09-04

ApplicantGhg Medizin-Elektronik AG
Decision Date1990-09-04
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER) is the device name listed in this FDA 510(k) record. The listed applicant is Ghg Medizin-Elektronik AG. It received FDA 510(k) clearance on 1990-09-04 under 510(k) number K900331. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)?

TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER) is a medical device that received FDA 510(k) clearance on 1990-09-04. The listed applicant is Ghg Medizin-Elektronik AG. The 510(k) number is K900331.

When did TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER) receive FDA 510(k) clearance?

TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER) received FDA 510(k) clearance on 1990-09-04, under 510(k) number K900331.

Who is the listed applicant for TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)?

The FDA 510(k) record lists Ghg Medizin-Elektronik AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)?

The FDA product code for TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER) is BZG.

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Related Devices (Code: BZG)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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