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FDA 510(k)

SUNBED/SUNROOF OR SUNCOUCH/SUNSKY

K-Number: K801542 · 1980-08-20

ApplicantSunfit, Inc.
Decision Date1980-08-20
Product CodeLEJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUNBED/SUNROOF OR SUNCOUCH/SUNSKY is the device name listed in this FDA 510(k) record. The listed applicant is Sunfit, Inc.. It received FDA 510(k) clearance on 1980-08-20 under 510(k) number K801542. 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 SUNBED/SUNROOF OR SUNCOUCH/SUNSKY?

SUNBED/SUNROOF OR SUNCOUCH/SUNSKY is a medical device that received FDA 510(k) clearance on 1980-08-20. The listed applicant is Sunfit, Inc.. The 510(k) number is K801542.

When did SUNBED/SUNROOF OR SUNCOUCH/SUNSKY receive FDA 510(k) clearance?

SUNBED/SUNROOF OR SUNCOUCH/SUNSKY received FDA 510(k) clearance on 1980-08-20, under 510(k) number K801542.

Who is the listed applicant for SUNBED/SUNROOF OR SUNCOUCH/SUNSKY?

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

What is the FDA product code for SUNBED/SUNROOF OR SUNCOUCH/SUNSKY?

The FDA product code for SUNBED/SUNROOF OR SUNCOUCH/SUNSKY is LEJ.

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Other records listing Sunfit, Inc. 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.

K864485SUNFIT SUNLAMPK861533SUNFIT, ULTRA VIOLET LAMPS AND SUNLAMP PRODUCTS

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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