SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM— 510(k) K904396

Name: FDA 510(k) clearance K904396
Creator: U.S. Food and Drug Administration
Published: 1991-03-05

Substantially Equivalent

Simplex Medical Systems, Inc.

FDA 510(k) clearance K904396 for SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM, Substantially Equivalent on 1991-03-05. Applicant: Simplex Medical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Simplex Medical Systems, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1990-09-25
Decision date: 1991-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Download summary PDF View on FDA.gov ↗

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