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510(k) K890724

MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR by Bear Medical Systems, Inc. — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1989
Date Received
February 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type

Other clearances by Bear Medical Systems, Inc.

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  • 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)
  • 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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