DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME— 510(k) K944194

Name: FDA 510(k) clearance K944194
Creator: U.S. Food and Drug Administration
Published: 1994-09-13

Substantially Equivalent

Med-Tek Innovations, Inc.

FDA 510(k) clearance K944194 for DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME, Substantially Equivalent on 1994-09-13. Applicant: Med-Tek Innovations, Inc.. Device class: 1.

Clearance details

Applicant: Med-Tek Innovations, Inc.
Product code: Code BYD
Device class: Class 1
Regulation: 21 CFR 868.5375
Advisory panel: Anesthesiology
Date received: 1994-08-29
Decision date: 1994-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYD

view all

K955008 — HEAT & MOISTURE EXCHANGER1996-01-30
K954194 — DISPOSABLE HME/FILTER1995-10-20
K953580 — HEAT MOISTURE EXCHANGER1995-09-15
K953507 — TYPE 1 & 2 (HUMIDAIR I & II)1995-09-07
K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE1995-08-25

More clearances from Med-Tek Innovations, Inc.

view all

K913474 — RESPIRE DISPOSABLE PULMONARY RESUSCITATOR1993-02-03
K905288 — ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES1991-04-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.