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510(k) K032170

TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 by Medical Industries America, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2004
Date Received
July 16, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Medical Industries America, Inc.

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  • 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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