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510(k) K981277

PERIFORM by Verimed Holdings, Inc. — Product Code HIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1998
Date Received
April 8, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Perineometer
Device Class
Class II
Regulation Number
884.1425
Review Panel
GU
Submission Type

Other clearances by Verimed Holdings, Inc.

  • K954127 — BIOFEEDBACK DEVICE (November 14, 1995)
  • K951969 — MYOEXORCISER II FUAL (June 14, 1995)
  • K930670 — PHYACTION 787 (July 2, 1993)
  • K922550 — ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM) (December 10, 1992)
  • K913912 — VERIMED PERINEOMETER (June 16, 1992)
  • K893220 — VERIMED MYOEXORCISER VERISTIM (March 7, 1990)
  • K892649 — VERIMED MYOEXORCISER III (MYO III) (December 13, 1989)
  • K874212 — VERIMED MYO/PREMS (August 8, 1988)
  • K854193 — ELECTRO-MYOGRAPHIC PERINEOMETER (June 9, 1986)
  • K852963 — MYO-ACTUATOR (January 21, 1986)

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