PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT— 510(k) K912428

Name: FDA 510(k) clearance K912428
Creator: U.S. Food and Drug Administration
Published: 1991-08-09

Substantially Equivalent

Puritan Bennett Corp.

FDA 510(k) clearance K912428 for PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT, Substantially Equivalent on 1991-08-09. Applicant: Puritan Bennett Corp.. Device class: 2.

Clearance details

Applicant: Puritan Bennett Corp.
Product code: Code CBZ
Device class: Class 2
Regulation: 21 CFR 868.1170
Advisory panel: Anesthesiology
Date received: 1991-05-31
Decision date: 1991-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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