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FDA 510(k)

AUTO PRO

K-Number: K853378 · 1985-09-19

Decision Date1985-09-19
Product CodeNFB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUTO PRO is the device name listed in this FDA 510(k) record. The listed applicant is Respiration Technology, Inc.. It received FDA 510(k) clearance on 1985-09-19 under 510(k) number K853378. The device is classified under product code NFB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO PRO?

AUTO PRO is a medical device that received FDA 510(k) clearance on 1985-09-19. The listed applicant is Respiration Technology, Inc.. The 510(k) number is K853378.

When did AUTO PRO receive FDA 510(k) clearance?

AUTO PRO received FDA 510(k) clearance on 1985-09-19, under 510(k) number K853378.

Who is the listed applicant for AUTO PRO?

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

What is the FDA product code for AUTO PRO?

The FDA product code for AUTO PRO is NFB.

Related Devices (Code: NFB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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