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FDA 510(k)

RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL

K-Number: K864886 · 1987-03-06

ApplicantNims/Respitrace Corp.
Decision Date1987-03-06
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL is the device name listed in this FDA 510(k) record. The listed applicant is Nims/Respitrace Corp.. It received FDA 510(k) clearance on 1987-03-06 under 510(k) number K864886. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL?

RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL is a medical device that received FDA 510(k) clearance on 1987-03-06. The listed applicant is Nims/Respitrace Corp.. The 510(k) number is K864886.

When did RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL receive FDA 510(k) clearance?

RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL received FDA 510(k) clearance on 1987-03-06, under 510(k) number K864886.

Who is the listed applicant for RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL?

The FDA 510(k) record lists Nims/Respitrace Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL?

The FDA product code for RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL is BZK.

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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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