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510(k) K905593

SLEEPAP by Medical Industries America, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1991
Date Received
December 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

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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)

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