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FDA 510(k)

A.M.S. TEMP. SCAN 300

K-Number: K832135 · 1983-08-16

ApplicantAndon Medical Systems, Inc.
Decision Date1983-08-16
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

A.M.S. TEMP. SCAN 300 is the device name listed in this FDA 510(k) record. The listed applicant is Andon Medical Systems, Inc.. It received FDA 510(k) clearance on 1983-08-16 under 510(k) number K832135. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A.M.S. TEMP. SCAN 300?

A.M.S. TEMP. SCAN 300 is a medical device that received FDA 510(k) clearance on 1983-08-16. The listed applicant is Andon Medical Systems, Inc.. The 510(k) number is K832135.

When did A.M.S. TEMP. SCAN 300 receive FDA 510(k) clearance?

A.M.S. TEMP. SCAN 300 received FDA 510(k) clearance on 1983-08-16, under 510(k) number K832135.

Who is the listed applicant for A.M.S. TEMP. SCAN 300?

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

What is the FDA product code for A.M.S. TEMP. SCAN 300?

The FDA product code for A.M.S. TEMP. SCAN 300 is FLL.

Related Devices (Code: FLL)

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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