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510(k) K912071

SPACE(TM) 7500 by F.M. Wiest USA, Inc. — Product Code IKN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1991
Date Received
May 10, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromyograph, Diagnostic
Device Class
Class II
Regulation Number
890.1375
Review Panel
NE
Submission Type

Other clearances by F.M. Wiest USA, Inc.

  • K921871 — HYSTEROMAT(TM) 3700 (December 15, 1994)
  • K920574 — CAMSYS 6300 (February 17, 1993)
  • K920575 — MERKUR 4000 (July 23, 1992)
  • K915751 — URETEROMAT 4400 (April 24, 1992)
  • K911844 — HYSTEROFLATOR 1500 (November 21, 1991)
  • K910883 — LAPAROFLATOR ELECTRONIC 3509 (March 29, 1991)
  • K875137 — LAPAROFLATOR 3000, STANDARD AND ELECTRONIC (March 2, 1988)
  • K871181 — ARTHROCOMBI 5003 (September 29, 1987)
  • K871180 — ARTHRO AUTOMAT 5002 (September 29, 1987)
  • K865066 — ARTHROFLATOR (April 20, 1987)

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