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FDA 510(k)

RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL

K-Number: K903011 · 1991-03-29

ApplicantNon-Invasive Monitoring Systems, Inc.
Decision Date1991-03-29
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL is the device name listed in this FDA 510(k) record. The listed applicant is Non-Invasive Monitoring Systems, Inc.. It received FDA 510(k) clearance on 1991-03-29 under 510(k) number K903011. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL?

RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL is a medical device that received FDA 510(k) clearance on 1991-03-29. The listed applicant is Non-Invasive Monitoring Systems, Inc.. The 510(k) number is K903011.

When did RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL receive FDA 510(k) clearance?

RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL received FDA 510(k) clearance on 1991-03-29, under 510(k) number K903011.

Who is the listed applicant for RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL?

The FDA 510(k) record lists Non-Invasive Monitoring Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL?

The FDA product code for RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL is BZQ.

Related Clinical Trials

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Other records listing Non-Invasive Monitoring Systems, 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.

K012020RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PCK001369RESPIEVENTS, VERSION 4.2K942852RESPITRACE PTK942771RESPIEVENTSK884959RESPITRAK

Related Devices (Code: BZQ)

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.

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Official Source

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