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FDA 510(k)

ROTOLUX, SELECTOLUX, SHUTTERVUE

K-Number: K922079 · 1992-06-16

ApplicantAmerican Medical Sales, Inc.
Decision Date1992-06-16
Product CodeIXC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ROTOLUX, SELECTOLUX, SHUTTERVUE is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Sales, Inc.. It received FDA 510(k) clearance on 1992-06-16 under 510(k) number K922079. The device is classified under product code IXC. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTOLUX, SELECTOLUX, SHUTTERVUE?

ROTOLUX, SELECTOLUX, SHUTTERVUE is a medical device that received FDA 510(k) clearance on 1992-06-16. The listed applicant is American Medical Sales, Inc.. The 510(k) number is K922079.

When did ROTOLUX, SELECTOLUX, SHUTTERVUE receive FDA 510(k) clearance?

ROTOLUX, SELECTOLUX, SHUTTERVUE received FDA 510(k) clearance on 1992-06-16, under 510(k) number K922079.

Who is the listed applicant for ROTOLUX, SELECTOLUX, SHUTTERVUE?

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

What is the FDA product code for ROTOLUX, SELECTOLUX, SHUTTERVUE?

The FDA product code for ROTOLUX, SELECTOLUX, SHUTTERVUE is IXC.

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Other records listing American Medical Sales, 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.

K052537CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0K930230RADIOGRAPHIC WALL-MOUNTED CASSETTE HOLDER

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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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