FDA 510(k)

ULS 8-86

K-Number: K863163 · 1986-09-22

ApplicantAmerican Instrument Manufacturer'S, Inc.

Decision Date1986-09-22

Product CodeDYN

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ULS 8-86 is the device name listed in this FDA 510(k) record. The listed applicant is American Instrument Manufacturer'S, Inc.. It received FDA 510(k) clearance on 1986-09-22 under 510(k) number K863163. The device is classified under product code DYN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULS 8-86?

ULS 8-86 is a medical device that received FDA 510(k) clearance on 1986-09-22. The listed applicant is American Instrument Manufacturer'S, Inc.. The 510(k) number is K863163.

When did ULS 8-86 receive FDA 510(k) clearance?

ULS 8-86 received FDA 510(k) clearance on 1986-09-22, under 510(k) number K863163.

Who is the listed applicant for ULS 8-86?

The FDA 510(k) record lists American Instrument Manufacturer'S, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULS 8-86?

The FDA product code for ULS 8-86 is DYN.

Other records listing American Instrument Manufacturer'S, 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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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.