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510(k) K811991

SIMVAC by The Lynn Terrell Co. — Product Code CBO

K811991 is an FDA 510(k) premarket notification submitted by The Lynn Terrell Co. for the device "SIMVAC". The FDA issued a decision of Substantially Equivalent on August 12, 1981. The device falls under product code CBO (Attachment, Intermittent Mandatory Ventilation (Imv)), a Class II device regulated under 21 CFR 868.5955.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1981
Date Received
July 13, 1981
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 for product code CBO

  • K811908 — IMV MANIFOLDS (July 16, 1981)
  • K791912 — IMV FOR MONITORING #M-510 (October 9, 1979)
  • K791913 — IMV MANIFOLD #M-506 (October 9, 1979)
  • K791905 — IMV W/BAG & TUBING #M-508 (October 9, 1979)
  • K791909 — IMV BUSHING #M-513 (October 9, 1979)
  • K791911 — FALL-SAFE IMV #M-511 (October 9, 1979)
  • K791904 — IMV W/BAG & HOSES #M-509 (October 9, 1979)
  • K791906 — IMV W/BAG #M-507 (October 9, 1979)
  • K781706 — RESPIRATOR/GILL 1/SIMV (January 22, 1979)
  • K760891 — INSPIRON I.M.V. SET UP (December 9, 1976)

FDA data resources