Respirator/Gill 1/SIMV

FDA 510(k) K781706 · Chemetron Medical Products, Inc.

Substantially Equivalent

510(k) numberK781706

Submission

Device name
Respirator/Gill 1/SIMV
Applicant
Chemetron Medical Products, Inc.
Mchenry, IL, US
Received
October 10, 1978
Decision date
January 22, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CBO – Attachment, Intermittent Mandatory Ventilation (Imv)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5955
Specialty
Anesthesiology
Life-sustaining
Yes

Other 510(k)s with product code CBO

510(k)DeviceApplicantDecision
K811991SimvacCBO · Traditional The Lynn Terrell Co.08/12/1981SE
K811908Imv ManifoldsCBO · Traditional Airlife, Inc.07/16/1981SE
K791913Imv Manifold #M-506CBO · Traditional Mem Medical, Inc.10/09/1979SE
K791912Imv for Monitoring #M-510CBO · Traditional Mem Medical, Inc.10/09/1979SE
K791911Fall-Safe Imv #M-511CBO · Traditional Mem Medical, Inc.10/09/1979SE
K791909Imv Bushing #M-513CBO · Traditional Mem Medical, Inc.10/09/1979SE
K791906Imv W/Bag #M-507CBO · Traditional Mem Medical, Inc.10/09/1979SE
K791905Imv W/Bag & Tubing #M-508CBO · Traditional Mem Medical, Inc.10/09/1979SE
K791904Imv W/Bag & Hoses #M-509CBO · Traditional Mem Medical, Inc.10/09/1979SE
K760891Inspiron I.M.V. Set UpCBO · Traditional Inspiron Corp.12/09/1976SE

More from Inspiron Corp.

510(k)DeviceDecision
K781542Heated NebulizerCAF · Traditional 10/10/1978SE
K781537Nebulizer/HumidifierBTT · Traditional 10/10/1978SE
K781541FlometerCAX · Traditional 09/26/1978SE

Questions and answers

When was Respirator/Gill 1/SIMV cleared by the FDA?

Respirator/Gill 1/SIMV (K781706) received a 510(k) decision of Substantially Equivalent on January 22, 1979, 104 days after the submission was received.

What is the product code of K781706?

The FDA product code is CBO – Attachment, Intermittent Mandatory Ventilation (Imv), a Class II (moderate risk) device regulated under 21 CFR 868.5955.