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FDA 510(k)

TOP SUN MODELS 100,101,103 &139, 139-1, 139-3

K-Number: K853833 · 1985-10-24

ApplicantTop Sun America, Inc.
Decision Date1985-10-24
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TOP SUN MODELS 100,101,103 &139, 139-1, 139-3 is the device name listed in this FDA 510(k) record. The listed applicant is Top Sun America, Inc.. It received FDA 510(k) clearance on 1985-10-24 under 510(k) number K853833. 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 TOP SUN MODELS 100,101,103 &139, 139-1, 139-3?

TOP SUN MODELS 100,101,103 &139, 139-1, 139-3 is a medical device that received FDA 510(k) clearance on 1985-10-24. The listed applicant is Top Sun America, Inc.. The 510(k) number is K853833.

When did TOP SUN MODELS 100,101,103 &139, 139-1, 139-3 receive FDA 510(k) clearance?

TOP SUN MODELS 100,101,103 &139, 139-1, 139-3 received FDA 510(k) clearance on 1985-10-24, under 510(k) number K853833.

Who is the listed applicant for TOP SUN MODELS 100,101,103 &139, 139-1, 139-3?

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

What is the FDA product code for TOP SUN MODELS 100,101,103 &139, 139-1, 139-3?

The FDA product code for TOP SUN MODELS 100,101,103 &139, 139-1, 139-3 is FTC.

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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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