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FDA 510(k)

SYSTEMATE CK-TOTAL - 67206

K-Number: K843271 · 1984-09-07

ApplicantEm Diagnostic Systems, Inc.
Decision Date1984-09-07
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTEMATE CK-TOTAL - 67206 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 1984-09-07 under 510(k) number K843271. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEMATE CK-TOTAL - 67206?

SYSTEMATE CK-TOTAL - 67206 is a medical device that received FDA 510(k) clearance on 1984-09-07. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K843271.

When did SYSTEMATE CK-TOTAL - 67206 receive FDA 510(k) clearance?

SYSTEMATE CK-TOTAL - 67206 received FDA 510(k) clearance on 1984-09-07, under 510(k) number K843271.

Who is the listed applicant for SYSTEMATE CK-TOTAL - 67206?

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 CK-TOTAL - 67206?

The FDA product code for SYSTEMATE CK-TOTAL - 67206 is CGS.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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Related Devices (Code: CGS)

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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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