FDA 510(k)

HC PLUS

K-Number: K833563 · 1984-01-03

Decision Date1984-01-03

Product CodeJPK

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

HC PLUS 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 1984-01-03 under 510(k) number K833563. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HC PLUS?

HC PLUS is a medical device that received FDA 510(k) clearance on 1984-01-03. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K833563.

When did HC PLUS receive FDA 510(k) clearance?

HC PLUS received FDA 510(k) clearance on 1984-01-03, under 510(k) number K833563.

Who is the listed applicant for HC PLUS?

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 HC PLUS?

The FDA product code for HC PLUS is JPK.

Other records listing Coulter Electronics, Inc. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.