FDA 510(k)

USCOM 1A

K-Number: K043139 · 2005-02-15

Decision Date2005-02-15

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

USCOM 1A is the device name listed in this FDA 510(k) record. The listed applicant is Uscom, Ltd.. It received FDA 510(k) clearance on 2005-02-15 under 510(k) number K043139. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the USCOM 1A?

USCOM 1A is a medical device that received FDA 510(k) clearance on 2005-02-15. The listed applicant is Uscom, Ltd.. The 510(k) number is K043139.

When did USCOM 1A receive FDA 510(k) clearance?

USCOM 1A received FDA 510(k) clearance on 2005-02-15, under 510(k) number K043139.

Who is the listed applicant for USCOM 1A?

The FDA 510(k) record lists Uscom, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for USCOM 1A?

The FDA product code for USCOM 1A is IYN.

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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.