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FDA 510(k)

I.S.M. PRODUCT FAMILY MODEL R3600C

K-Number: K854170 · 1985-11-08

ApplicantIntl. Solarium Manufacturer, Inc.
Decision Date1985-11-08
Product CodeFTC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

I.S.M. PRODUCT FAMILY MODEL R3600C is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Solarium Manufacturer, Inc.. It received FDA 510(k) clearance on 1985-11-08 under 510(k) number K854170. 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 I.S.M. PRODUCT FAMILY MODEL R3600C?

I.S.M. PRODUCT FAMILY MODEL R3600C is a medical device that received FDA 510(k) clearance on 1985-11-08. The listed applicant is Intl. Solarium Manufacturer, Inc.. The 510(k) number is K854170.

When did I.S.M. PRODUCT FAMILY MODEL R3600C receive FDA 510(k) clearance?

I.S.M. PRODUCT FAMILY MODEL R3600C received FDA 510(k) clearance on 1985-11-08, under 510(k) number K854170.

Who is the listed applicant for I.S.M. PRODUCT FAMILY MODEL R3600C?

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

What is the FDA product code for I.S.M. PRODUCT FAMILY MODEL R3600C?

The FDA product code for I.S.M. PRODUCT FAMILY MODEL R3600C is FTC.

Related Clinical Trials

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Other records listing Intl. Solarium Manufacturer, 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.

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Related Devices (Code: FTC)

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Official Source

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