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FDA 510(k)

Q-PLEX 1

K-Number: K881235 · 1989-03-31

ApplicantQuinton, Inc.
Decision Date1989-03-31
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Q-PLEX 1 is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1989-03-31 under 510(k) number K881235. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q-PLEX 1?

Q-PLEX 1 is a medical device that received FDA 510(k) clearance on 1989-03-31. The listed applicant is Quinton, Inc.. The 510(k) number is K881235.

When did Q-PLEX 1 receive FDA 510(k) clearance?

Q-PLEX 1 received FDA 510(k) clearance on 1989-03-31, under 510(k) number K881235.

Who is the listed applicant for Q-PLEX 1?

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

What is the FDA product code for Q-PLEX 1?

The FDA product code for Q-PLEX 1 is BZC.

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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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