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FDA 510(k)

K60 HABITAT ENVIRONMENT ENCLOSURE

K-Number: K813208 · 1981-12-31

ApplicantKohler
Decision Date1981-12-31
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

K60 HABITAT ENVIRONMENT ENCLOSURE is the device name listed in this FDA 510(k) record. The listed applicant is Kohler. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813208. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K60 HABITAT ENVIRONMENT ENCLOSURE?

K60 HABITAT ENVIRONMENT ENCLOSURE is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Kohler. The 510(k) number is K813208.

When did K60 HABITAT ENVIRONMENT ENCLOSURE receive FDA 510(k) clearance?

K60 HABITAT ENVIRONMENT ENCLOSURE received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813208.

Who is the listed applicant for K60 HABITAT ENVIRONMENT ENCLOSURE?

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

What is the FDA product code for K60 HABITAT ENVIRONMENT ENCLOSURE?

The FDA product code for K60 HABITAT ENVIRONMENT ENCLOSURE is LEJ.

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.

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Other records listing Kohler 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.

K813207K51,K52 ENVIRONMENT ENCLOSURE

Related Devices (Code: LEJ)

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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