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FDA 510(k)

GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR

K-Number: K991411 · 1999-04-28

ApplicantGereonics, Inc.
Decision Date1999-04-28
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Gereonics, Inc.. It received FDA 510(k) clearance on 1999-04-28 under 510(k) number K991411. 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 GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR?

GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR is a medical device that received FDA 510(k) clearance on 1999-04-28. The listed applicant is Gereonics, Inc.. The 510(k) number is K991411.

When did GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR receive FDA 510(k) clearance?

GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR received FDA 510(k) clearance on 1999-04-28, under 510(k) number K991411.

Who is the listed applicant for GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR?

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

What is the FDA product code for GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR?

The FDA product code for GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR is BZQ.

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Other records listing Gereonics, 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.

K062883GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSORK983449GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSORK861099GEREONICS BIOPOTENTIAL SKIN ELECTRODES

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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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