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FDA 510(k)

HEPACRON PUREAIR-ZONE SYSTEM

K-Number: K862432 · 1986-10-16

ApplicantHepacron, Inc.
Decision Date1986-10-16
Product CodeFRF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEPACRON PUREAIR-ZONE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hepacron, Inc.. It received FDA 510(k) clearance on 1986-10-16 under 510(k) number K862432. The device is classified under product code FRF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEPACRON PUREAIR-ZONE SYSTEM?

HEPACRON PUREAIR-ZONE SYSTEM is a medical device that received FDA 510(k) clearance on 1986-10-16. The listed applicant is Hepacron, Inc.. The 510(k) number is K862432.

When did HEPACRON PUREAIR-ZONE SYSTEM receive FDA 510(k) clearance?

HEPACRON PUREAIR-ZONE SYSTEM received FDA 510(k) clearance on 1986-10-16, under 510(k) number K862432.

Who is the listed applicant for HEPACRON PUREAIR-ZONE SYSTEM?

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

What is the FDA product code for HEPACRON PUREAIR-ZONE SYSTEM?

The FDA product code for HEPACRON PUREAIR-ZONE SYSTEM is FRF.

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Related Devices (Code: FRF)

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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.

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