FDA 510(k)

VERA 103

K-Number: K897143 · 1990-04-27

Decision Date1990-04-27

Product CodeLYN

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

VERA 103 is the device name listed in this FDA 510(k) record. The listed applicant is Madsen North America, Inc.. It received FDA 510(k) clearance on 1990-04-27 under 510(k) number K897143. The device is classified under product code LYN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERA 103?

VERA 103 is a medical device that received FDA 510(k) clearance on 1990-04-27. The listed applicant is Madsen North America, Inc.. The 510(k) number is K897143.

When did VERA 103 receive FDA 510(k) clearance?

VERA 103 received FDA 510(k) clearance on 1990-04-27, under 510(k) number K897143.

Who is the listed applicant for VERA 103?

The FDA 510(k) record lists Madsen North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERA 103?

The FDA product code for VERA 103 is LYN.

Other records listing Madsen North America, 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.

K896710MIDIMATE 622 K896401MICROMATE 304

Related Devices (Code: LYN)

K950995SENSICARE SYNTHETIC, SURGICAL GLOVE LINERBd Becton Dickinson Vacutainer Systems Preanalytic K880259VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADVColorado Hearing Systems, Inc.

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.