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510(k) K915321

BTM-200 (PROPOSED) POWERED MUSCLE STIMULATOR by Bt Medical Co., Inc. — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1992
Date Received
November 22, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by Bt Medical Co., Inc.

  • K931268 — URETERAL COMPRESSION DEVICE (July 19, 1993)
  • K930885 — PNEUMATIC COMPRESSION DEVICE (July 13, 1993)
  • K931269 — LEAD APRON (June 2, 1993)
  • K914999 — BTM-100 POWERED MUSCLE STIMULATOR (PROPOSED) (April 23, 1992)

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