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FDA 510(k)

SPIROMETEO & LUNG EXERCISER, 4601

K-Number: K771532 · 1977-08-26

Decision Date1977-08-26
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPIROMETEO & LUNG EXERCISER, 4601 is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Laboratories. It received FDA 510(k) clearance on 1977-08-26 under 510(k) number K771532. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPIROMETEO & LUNG EXERCISER, 4601?

SPIROMETEO & LUNG EXERCISER, 4601 is a medical device that received FDA 510(k) clearance on 1977-08-26. The listed applicant is Boehringer Laboratories. The 510(k) number is K771532.

When did SPIROMETEO & LUNG EXERCISER, 4601 receive FDA 510(k) clearance?

SPIROMETEO & LUNG EXERCISER, 4601 received FDA 510(k) clearance on 1977-08-26, under 510(k) number K771532.

Who is the listed applicant for SPIROMETEO & LUNG EXERCISER, 4601?

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

What is the FDA product code for SPIROMETEO & LUNG EXERCISER, 4601?

The FDA product code for SPIROMETEO & LUNG EXERCISER, 4601 is BWF.

Related Clinical Trials

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.

Other records listing Boehringer Laboratories as applicant

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.

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Related Devices (Code: BWF)

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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