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510(k) K930885

PNEUMATIC COMPRESSION DEVICE by Bt Medical Co., Inc. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1993
Date Received
February 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Other clearances by Bt Medical Co., Inc.

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  • K931269 — LEAD APRON (June 2, 1993)
  • K915321 — BTM-200 (PROPOSED) POWERED MUSCLE STIMULATOR (July 17, 1992)
  • K914999 — BTM-100 POWERED MUSCLE STIMULATOR (PROPOSED) (April 23, 1992)

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