Home / 510(k) Clearances / K943915

510(k) K943915

HEAT AND MOISTURE EXCHANGER FILTER (HME) by Medicomp, Inc. — Product Code BYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 1994
Date Received
August 11, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condenser, Heat And Moisture (Artificial Nose)
Device Class
Class I
Regulation Number
868.5375
Review Panel
AN
Submission Type

Other clearances by Medicomp, Inc.

  • K173170 — Epicardia Anywhere (January 10, 2018)
  • K161916 — TelePatch Cardiac Monitor (December 21, 2016)
  • K091696 — SAVI WIRELESS, MODEL PM500 (October 26, 2009)
  • K090834 — EPICARDIA 5000 (May 15, 2009)
  • K043454 — CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 (March 24, 2005)
  • K981119 — CARDIOPAL MODEL NUMBER PM20 (October 14, 1998)
  • K952846 — EPICARDIA (September 18, 1995)
  • K900207 — EPICARDIA 4000 (July 31, 1990)
  • K883103 — EPICARDIA PC/FC (September 22, 1988)
  • K881770 — EPICARDIA LE/FD (May 31, 1988)

Other clearances for product code BYD

  • K955008 — HEAT & MOISTURE EXCHANGER (January 30, 1996)
  • K954194 — DISPOSABLE HME/FILTER (October 20, 1995)
  • K953580 — HEAT MOISTURE EXCHANGER (September 15, 1995)
  • K953507 — TYPE 1 & 2 (HUMIDAIR I & II) (September 7, 1995)
  • K953619 — WARM N WET HME W/LUER ADAPTER (August 25, 1995)
  • K953620 — WARM N WET HMEF W/LUER ADAPTER (August 25, 1995)
  • K953540 — EEE (August 25, 1995)
  • K953544 — HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (August 25, 1995)
  • K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (August 25, 1995)
  • K952845 — HUMID-VENT TRACH-VENT (July 25, 1995)