PDS MODEL 3000 ADULT RESPIRATION MODULE— 510(k) K802046

Name: FDA 510(k) clearance K802046
Creator: U.S. Food and Drug Administration
Published: 1980-09-16

Substantially Equivalent

General Electric Co.

FDA 510(k) clearance K802046 for PDS MODEL 3000 ADULT RESPIRATION MODULE, Substantially Equivalent on 1980-09-16. Applicant: General Electric Co.. Device class: 2.

Clearance details

Applicant: General Electric Co.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1980-08-25
Decision date: 1980-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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