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510(k) K050990

REMREST HEATED HUMIDIFIER by Medical Industries America, Inc. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2005
Date Received
April 19, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Medical Industries America, Inc.

  • K032170 — TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 (May 28, 2004)
  • K002763 — REMREST (May 4, 2001)
  • K011053 — OPTIMA (April 20, 2001)
  • K964078 — 3050 SPORT-NEB (January 10, 1997)
  • K943990 — 3000 AEROSOL TWO (March 21, 1995)
  • K942444 — 3002 AEROMAX (March 10, 1995)
  • K941961 — 605 VACU-MAX (March 2, 1995)
  • K942208 — 4003 AEROLITE (February 24, 1995)
  • K940630 — 503 MAXI COMPRESSOR (February 21, 1995)
  • K905593 — SLEEPAP (April 23, 1991)

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