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FDA 510(k)

COULTER MH017

K-Number: K921567 · 1992-07-06

ApplicantCoulter Electronics, Inc.
Decision Date1992-07-06
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER MH017 is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1992-07-06 under 510(k) number K921567. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COULTER MH017?

COULTER MH017 is a medical device that received FDA 510(k) clearance on 1992-07-06. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K921567.

When did COULTER MH017 receive FDA 510(k) clearance?

COULTER MH017 received FDA 510(k) clearance on 1992-07-06, under 510(k) number K921567.

Who is the listed applicant for COULTER MH017?

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

What is the FDA product code for COULTER MH017?

The FDA product code for COULTER MH017 is GKZ.

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Other records listing Coulter Electronics, Inc. as applicant

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Related Devices (Code: GKZ)

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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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