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510(k) K944819

KRDL 2000 by Physicians Consulting, Inc. — Product Code BXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1995
Date Received
September 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type

Other clearances by Physicians Consulting, Inc.

  • K952369 — KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE (August 7, 1995)

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  • K955105 — BTE CPM-10 (December 29, 1995)
  • K955106 — BTE CPM-20 (December 29, 1995)
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  • K950755 — FLEXMATE K500 (October 5, 1995)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)
  • K951029 — HAMEX ONE (September 15, 1995)