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510(k) K875305

MODEL UCA / SPEC SYSTEM UCA by Spec Systems, Inc. — Product Code FZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1988
Date Received
December 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Air Handling, Room
Device Class
Class II
Regulation Number
878.5070
Review Panel
SU
Submission Type

Other clearances by Spec Systems, Inc.

  • K821165 — SONIC MODEL 8711 HEARING AID (May 24, 1982)

Other clearances for product code FZH

  • K923233 — CARDIO-PAK LAPAROTOMY PACK (March 20, 1993)
  • K871901 — ULTRAFLOW (June 1, 1987)
  • K770084 — OPERATING ROOM VENTILATOR (February 23, 1977)