GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR— 510(k) K983449

Name: FDA 510(k) clearance K983449
Creator: U.S. Food and Drug Administration
Published: 1999-02-08

Substantially Equivalent

Gereonics, Inc.

FDA 510(k) clearance K983449 for GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR, Substantially Equivalent on 1999-02-08. Applicant: Gereonics, Inc.. Device class: 2.

Clearance details

Applicant: Gereonics, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1998-09-30
Decision date: 1999-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fallbrook, CA, US

Download summary PDF View on FDA.gov ↗

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