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FDA 510(k)

RESPAKIT

K-Number: K892053 · 1989-04-27

ApplicantProtectical Health & Safety , Ltd.
Decision Date1989-04-27
Product CodeCAE
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPAKIT is the device name listed in this FDA 510(k) record. The listed applicant is Protectical Health & Safety , Ltd.. It received FDA 510(k) clearance on 1989-04-27 under 510(k) number K892053. The device is classified under product code CAE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPAKIT?

RESPAKIT is a medical device that received FDA 510(k) clearance on 1989-04-27. The listed applicant is Protectical Health & Safety , Ltd.. The 510(k) number is K892053.

When did RESPAKIT receive FDA 510(k) clearance?

RESPAKIT received FDA 510(k) clearance on 1989-04-27, under 510(k) number K892053.

Who is the listed applicant for RESPAKIT?

The FDA 510(k) record lists Protectical Health & Safety , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPAKIT?

The FDA product code for RESPAKIT is CAE.

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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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