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FDA 510(k)

THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES

K-Number: K980106 · 1998-08-03

ApplicantProma, Inc.
Decision Date1998-08-03
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Proma, Inc.. It received FDA 510(k) clearance on 1998-08-03 under 510(k) number K980106. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES?

THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1998-08-03. The listed applicant is Proma, Inc.. The 510(k) number is K980106.

When did THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 1998-08-03, under 510(k) number K980106.

Who is the listed applicant for THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES?

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

What is the FDA product code for THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES?

The FDA product code for THE PROMA PERCEPTION, RESPONSE AND COMPASS SYSTEM AND ACCESSORIES is EIA.

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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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