FDA 510(k)

2 FR KELMAN CHAMBER MAINTAINER

K-Number: K792096 · 1979-11-16

Decision Date1979-11-16

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

2 FR KELMAN CHAMBER MAINTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Heyer Schulte Corp.. It received FDA 510(k) clearance on 1979-11-16 under 510(k) number K792096. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 2 FR KELMAN CHAMBER MAINTAINER?

2 FR KELMAN CHAMBER MAINTAINER is a medical device that received FDA 510(k) clearance on 1979-11-16. The listed applicant is Heyer Schulte Corp.. The 510(k) number is K792096.

When did 2 FR KELMAN CHAMBER MAINTAINER receive FDA 510(k) clearance?

2 FR KELMAN CHAMBER MAINTAINER received FDA 510(k) clearance on 1979-11-16, under 510(k) number K792096.

Who is the listed applicant for 2 FR KELMAN CHAMBER MAINTAINER?

The FDA 510(k) record lists Heyer Schulte Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2 FR KELMAN CHAMBER MAINTAINER?

The FDA product code for 2 FR KELMAN CHAMBER MAINTAINER is FMI.

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Other records listing Heyer Schulte Corp. as applicant

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Related Devices (Code: FMI)

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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.