Home / 510(k) Clearances / K912619

510(k) K912619

BEAR 7 VENTILATOR by Bear Medical Systems, Inc. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1992
Date Received
June 13, 1991
Clearance Type
Traditional
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)
  • K983981 — BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET (November 20, 1998)
  • 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)

Other clearances for product code CBK

  • K251888 — VPAP Pediatric Face Mask (March 12, 2026)
  • K232365 — Vivo 45 LS (December 19, 2025)
  • K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits (September 10, 2025)
  • K243767 — SV600, SV800 Ventilator (August 28, 2025)
  • K251133 — AVEA disposable expiratory filter/water trap (11790) (May 8, 2025)
  • K243394 — AF531 Oro-Nasal SE Face Mask (December 30, 2024)
  • K233486 — 731 Series Ventilator (December 13, 2024)
  • K223120 — Ventoux VC2; Ventoux VC3 (December 2, 2024)
  • K241135 — RESPOND(R) Ventilator (November 13, 2024)
  • K241943 — Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 (August 28, 2024)