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FDA 510(k)

THE LUNG GYM (XLATOR AND NLATOR)

K-Number: K861564 · 1986-08-07

ApplicantEl-Fax Company, Inc.
Decision Date1986-08-07
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

THE LUNG GYM (XLATOR AND NLATOR) is the device name listed in this FDA 510(k) record. The listed applicant is El-Fax Company, Inc.. It received FDA 510(k) clearance on 1986-08-07 under 510(k) number K861564. 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 THE LUNG GYM (XLATOR AND NLATOR)?

THE LUNG GYM (XLATOR AND NLATOR) is a medical device that received FDA 510(k) clearance on 1986-08-07. The listed applicant is El-Fax Company, Inc.. The 510(k) number is K861564.

When did THE LUNG GYM (XLATOR AND NLATOR) receive FDA 510(k) clearance?

THE LUNG GYM (XLATOR AND NLATOR) received FDA 510(k) clearance on 1986-08-07, under 510(k) number K861564.

Who is the listed applicant for THE LUNG GYM (XLATOR AND NLATOR)?

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

What is the FDA product code for THE LUNG GYM (XLATOR AND NLATOR)?

The FDA product code for THE LUNG GYM (XLATOR AND NLATOR) is BWF.

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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.

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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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