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510(k) K830649

SUTTER CPM 2000 by Sutter Biomedical, Inc. — Product Code BXB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1983
Date Received
March 1, 1983
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 Sutter Biomedical, Inc.

  • K875249 — SUTTER PHALANGEAL CAP (February 3, 1988)
  • K870200 — SUTTER FINGER JOINT PROSTHESIS (October 9, 1987)
  • K861983 — SUTTER LESSER METATARSAL CAP (September 8, 1986)
  • K850274 — SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT (April 25, 1985)
  • K830974 — SUTTER CPM 5000 (April 12, 1983)
  • K823539 — SUTTER CPM (January 14, 1983)
  • K820813 — LESSER METATARSAL PHALANG. JOINT PROSTH (May 21, 1982)
  • K820083 — SUTTER CPM (January 28, 1982)
  • K812691 — SILICONE IMPLANTS (November 16, 1981)
  • K802342 — PROXIMAL INTERPHALANGEAL JOINT IMPLANT (October 14, 1981)

Other clearances for product code BXB

  • K072887 — G-TRAINER MEDICAL (January 25, 2008)
  • K003272 — FLO-BOOT (April 4, 2001)
  • K952975 — ANKLE CALF EXERCISER PHLEBOPUMP (September 25, 1996)
  • K953456 — E-Z FLEX (January 26, 1996)
  • K955105 — BTE CPM-10 (December 29, 1995)
  • K955106 — BTE CPM-20 (December 29, 1995)
  • K951028 — HAMEX TWO (December 11, 1995)
  • K950755 — FLEXMATE K500 (October 5, 1995)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)
  • K951029 — HAMEX ONE (September 15, 1995)