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510(k) K872660

BEAR NVM-1 by Bear Medical Systems, Inc. — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1988
Date Received
July 7, 1987
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.

  • K992788 — BEAR CUB 750 PSV (September 16, 1999)
  • K983981 — BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET (November 20, 1998)
  • 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)
  • K873634 — BEAR VH-820 HUMIDIFIER (December 2, 1987)

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  • K120087 — EXSPIRON (September 26, 2012)
  • K103578 — PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST (June 2, 2011)
  • K091853 — WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-01 (September 21, 2009)
  • K092217 — MERCURY VCO2 (August 21, 2009)