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510(k) K983981

BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE by Bear Medical Systems, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1998
Date Received
November 9, 1998
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Bear Medical Systems, Inc.

  • K992788 — BEAR CUB 750 PSV (September 16, 1999)
  • K912619 — BEAR 7 VENTILATOR (June 11, 1992)
  • K900637 — BEAR CEM CONTROLLER (August 3, 1990)
  • K896315 — BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY (January 22, 1990)
  • K893034 — VHS 820 HUMIDIFIER, MODIFICATION (July 14, 1989)
  • K890724 — MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR (March 30, 1989)
  • K882764 — BEAR EVC-100 CONTROLLER (September 30, 1988)
  • K881335 — BEAR 3 VENTILATOR (August 4, 1988)
  • K872660 — BEAR NVM-1 (February 12, 1988)
  • K873634 — BEAR VH-820 HUMIDIFIER (December 2, 1987)

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