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FDA 510(k)

PROTECH PLUS

K-Number: K983547 · 1999-01-07

ApplicantProtech, Inc.
Decision Date1999-01-07
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROTECH PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Protech, Inc.. It received FDA 510(k) clearance on 1999-01-07 under 510(k) number K983547. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTECH PLUS?

PROTECH PLUS is a medical device that received FDA 510(k) clearance on 1999-01-07. The listed applicant is Protech, Inc.. The 510(k) number is K983547.

When did PROTECH PLUS receive FDA 510(k) clearance?

PROTECH PLUS received FDA 510(k) clearance on 1999-01-07, under 510(k) number K983547.

Who is the listed applicant for PROTECH PLUS?

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

What is the FDA product code for PROTECH PLUS?

The FDA product code for PROTECH PLUS is EBI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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