HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER— 510(k) K862020

Name: FDA 510(k) clearance K862020
Creator: U.S. Food and Drug Administration
Published: 1986-06-30

Substantially Equivalent

Intertech/Ohio

FDA 510(k) clearance K862020 for HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER, Substantially Equivalent on 1986-06-30. Applicant: Intertech/Ohio. Device class: 1.

Clearance details

Applicant: Intertech/Ohio
Product code: Code BYD
Device class: Class 1
Regulation: 21 CFR 868.5375
Advisory panel: Anesthesiology
Date received: 1986-05-28
Decision date: 1986-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Myers, FL, 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 Intertech/Ohio

view all

K895144 — INTERTECH METERED DOSE ELBOW1989-10-19
K890346 — INTERTECH UNIVERSAL HYDROPHOBIC FILTER1989-03-01
K884525 — PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT1988-12-16
K884526 — ADULT RESUSCITATOR WITH MASK AND FILTER1988-11-16
K882204 — RESUSCITATOR VALVE ASSEMBLY W/FILTER1988-07-08

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