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FDA 510(k)

COULTER 5P CONTROL

K-Number: K885028 · 1989-02-16

ApplicantCoulter Electronics, Inc.
Decision Date1989-02-16
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COULTER 5P CONTROL 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 1989-02-16 under 510(k) number K885028. 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 5P CONTROL?

COULTER 5P CONTROL is a medical device that received FDA 510(k) clearance on 1989-02-16. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K885028.

When did COULTER 5P CONTROL receive FDA 510(k) clearance?

COULTER 5P CONTROL received FDA 510(k) clearance on 1989-02-16, under 510(k) number K885028.

Who is the listed applicant for COULTER 5P CONTROL?

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 5P CONTROL?

The FDA product code for COULTER 5P CONTROL is GKZ.

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Other records listing Coulter Electronics, 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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