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FDA 510(k)

SUNSHOWER MODEL HU-01-12L

K-Number: K850493 · 1985-02-28

ApplicantSunthetic Engineering, Inc.
Decision Date1985-02-28
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SUNSHOWER MODEL HU-01-12L is the device name listed in this FDA 510(k) record. The listed applicant is Sunthetic Engineering, Inc.. It received FDA 510(k) clearance on 1985-02-28 under 510(k) number K850493. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUNSHOWER MODEL HU-01-12L?

SUNSHOWER MODEL HU-01-12L is a medical device that received FDA 510(k) clearance on 1985-02-28. The listed applicant is Sunthetic Engineering, Inc.. The 510(k) number is K850493.

When did SUNSHOWER MODEL HU-01-12L receive FDA 510(k) clearance?

SUNSHOWER MODEL HU-01-12L received FDA 510(k) clearance on 1985-02-28, under 510(k) number K850493.

Who is the listed applicant for SUNSHOWER MODEL HU-01-12L?

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

What is the FDA product code for SUNSHOWER MODEL HU-01-12L?

The FDA product code for SUNSHOWER MODEL HU-01-12L is FTC.

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Other records listing Sunthetic Engineering, 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.

K862263PERSUNAL TAN, MODEL NO. HU-0208L

Related Devices (Code: FTC)

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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