NEONATAL BREATHING CIRCUIT SYSTEM— 510(k) K801087

Name: FDA 510(k) clearance K801087
Creator: U.S. Food and Drug Administration
Published: 1980-05-23

Substantially Equivalent

Isothermal Systems, Inc.

FDA 510(k) clearance K801087 for NEONATAL BREATHING CIRCUIT SYSTEM, Substantially Equivalent on 1980-05-23. Applicant: Isothermal Systems, Inc.. Device class: 1.

Clearance details

Applicant: Isothermal Systems, Inc.
Product code: Code BZO
Device class: Class 1
Regulation: 21 CFR 868.5975
Advisory panel: Anesthesiology
Date received: 1980-05-07
Decision date: 1980-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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