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FDA 510(k)

SYSTEMATE GLUCOSE 67216

K-Number: K843150 · 1984-08-27

ApplicantEm Diagnostic Systems, Inc.
Decision Date1984-08-27
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTEMATE GLUCOSE 67216 is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1984-08-27 under 510(k) number K843150. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEMATE GLUCOSE 67216?

SYSTEMATE GLUCOSE 67216 is a medical device that received FDA 510(k) clearance on 1984-08-27. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K843150.

When did SYSTEMATE GLUCOSE 67216 receive FDA 510(k) clearance?

SYSTEMATE GLUCOSE 67216 received FDA 510(k) clearance on 1984-08-27, under 510(k) number K843150.

Who is the listed applicant for SYSTEMATE GLUCOSE 67216?

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

What is the FDA product code for SYSTEMATE GLUCOSE 67216?

The FDA product code for SYSTEMATE GLUCOSE 67216 is CFR.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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Related Devices (Code: CFR)

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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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