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510(k) K942530

ART-ASSIST MODEL AA-1000 by Aci Medical, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1996
Date Received
May 27, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

Other clearances by Aci Medical, Inc.

  • K131146 — ARTASSIST AND VENASSIST (February 10, 2014)
  • K903894 — VENAPULSE MODELS VP-25 AND VP-50 (April 3, 1991)
  • K903532 — UNNA-SLEEVE(TM) (November 2, 1990)
  • K881291 — AIR PLETHYSMOGRAPH MODEL APG-1000 (October 14, 1988)
  • K861645 — MICRO-TRACHEOSTOMY CARE KIT (May 9, 1986)
  • K844309 — IV RATEMETER (January 22, 1985)

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