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FDA 510(k)

PMP4 SPIROPRO

K-Number: K050853 · 2005-05-04

ApplicantCard Guard Scientific Survival , Ltd.
Decision Date2005-05-04
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PMP4 SPIROPRO is the device name listed in this FDA 510(k) record. The listed applicant is Card Guard Scientific Survival , Ltd.. It received FDA 510(k) clearance on 2005-05-04 under 510(k) number K050853. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PMP4 SPIROPRO?

PMP4 SPIROPRO is a medical device that received FDA 510(k) clearance on 2005-05-04. The listed applicant is Card Guard Scientific Survival , Ltd.. The 510(k) number is K050853.

When did PMP4 SPIROPRO receive FDA 510(k) clearance?

PMP4 SPIROPRO received FDA 510(k) clearance on 2005-05-04, under 510(k) number K050853.

Who is the listed applicant for PMP4 SPIROPRO?

The FDA 510(k) record lists Card Guard Scientific Survival , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PMP4 SPIROPRO?

The FDA product code for PMP4 SPIROPRO is BZH.

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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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