DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER— 510(k) K945657

Name: FDA 510(k) clearance K945657
Creator: U.S. Food and Drug Administration
Published: 1994-12-07

Substantially Equivalent

Tec II Medical, Inc.

FDA 510(k) clearance K945657 for DISPOSABLE HEAT AND MOSITURE EXCHANGER AND HME/FILTER, Substantially Equivalent on 1994-12-07. Applicant: Tec II Medical, Inc.. Device class: 1.

Clearance details

Applicant: Tec II Medical, Inc.
Product code: Code BYD
Device class: Class 1
Regulation: 21 CFR 868.5375
Advisory panel: Anesthesiology
Date received: 1994-11-17
Decision date: 1994-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winfield, IL, US

Download summary PDF View on FDA.gov ↗

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