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510(k) K781706

RESPIRATOR/GILL 1/SIMV by Chemetron Medical Products, Inc. — Product Code CBO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1979
Date Received
October 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Intermittent Mandatory Ventilation (Imv)
Device Class
Class II
Regulation Number
868.5955
Review Panel
AN
Submission Type

Other clearances by Chemetron Medical Products, Inc.

  • K781542 — HEATED NEBULIZER (October 10, 1978)
  • K781537 — NEBULIZER/HUMIDIFIER (October 10, 1978)
  • K781541 — FLOMETER (September 26, 1978)

Other clearances for product code CBO

  • K811991 — SIMVAC (August 12, 1981)
  • K811908 — IMV MANIFOLDS (July 16, 1981)
  • K791912 — IMV FOR MONITORING #M-510 (October 9, 1979)
  • K791913 — IMV MANIFOLD #M-506 (October 9, 1979)
  • K791906 — IMV W/BAG #M-507 (October 9, 1979)
  • K791909 — IMV BUSHING #M-513 (October 9, 1979)
  • K791905 — IMV W/BAG & TUBING #M-508 (October 9, 1979)
  • K791904 — IMV W/BAG & HOSES #M-509 (October 9, 1979)
  • K791911 — FALL-SAFE IMV #M-511 (October 9, 1979)
  • K760891 — INSPIRON I.M.V. SET UP (December 9, 1976)