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FDA 510(k)

EXHALED HYDROGEN MONITOR

K-Number: K820652 · 1982-04-01

ApplicantKeymed, Inc.
Decision Date1982-04-01
Product Code
DecisionSubstantially Equivalent

Device Summary

EXHALED HYDROGEN MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Keymed, Inc.. It received FDA 510(k) clearance on 1982-04-01 under 510(k) number K820652. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXHALED HYDROGEN MONITOR?

EXHALED HYDROGEN MONITOR is a medical device that received FDA 510(k) clearance on 1982-04-01. The listed applicant is Keymed, Inc.. The 510(k) number is K820652.

When did EXHALED HYDROGEN MONITOR receive FDA 510(k) clearance?

EXHALED HYDROGEN MONITOR received FDA 510(k) clearance on 1982-04-01, under 510(k) number K820652.

Who is the listed applicant for EXHALED HYDROGEN MONITOR?

The FDA 510(k) record lists Keymed, Inc. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Keymed, Inc. as applicant

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Official Source

View on FDA Database →

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

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