DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME— 510(k) K946209

Name: FDA 510(k) clearance K946209
Creator: U.S. Food and Drug Administration
Published: 1995-06-08

Substantially Equivalent

Med-Plastics Intl., Inc.

FDA 510(k) clearance K946209 for DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME, Substantially Equivalent on 1995-06-08. Applicant: Med-Plastics Intl., Inc.. Device class: 1.

Clearance details

Applicant: Med-Plastics Intl., Inc.
Product code: Code BYD
Device class: Class 1
Regulation: 21 CFR 868.5375
Advisory panel: Anesthesiology
Date received: 1994-12-21
Decision date: 1995-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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