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FDA 510(k)

BLOOD GLUCOSE MONITOR

K-Number: K834099 · 1984-02-03

ApplicantHealthdyne, Inc.
Decision Date1984-02-03
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD GLUCOSE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Healthdyne, Inc.. It received FDA 510(k) clearance on 1984-02-03 under 510(k) number K834099. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD GLUCOSE MONITOR?

BLOOD GLUCOSE MONITOR is a medical device that received FDA 510(k) clearance on 1984-02-03. The listed applicant is Healthdyne, Inc.. The 510(k) number is K834099.

When did BLOOD GLUCOSE MONITOR receive FDA 510(k) clearance?

BLOOD GLUCOSE MONITOR received FDA 510(k) clearance on 1984-02-03, under 510(k) number K834099.

Who is the listed applicant for BLOOD GLUCOSE MONITOR?

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

What is the FDA product code for BLOOD GLUCOSE MONITOR?

The FDA product code for BLOOD GLUCOSE MONITOR is JJQ.

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Related Devices (Code: JJQ)

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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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