I.P.P.B., Dis. W/Manifold/Nebulizer

FDA 510(k) K760221 · Manner Medical Products

Substantially Equivalent

510(k) numberK760221

Submission

Device name
I.P.P.B., Dis. W/Manifold/Nebulizer
Applicant
Manner Medical Products
Mchenry, IL, US
Received
July 12, 1976
Decision date
August 3, 1976
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
K781706Respirator/Gill 1/SIMVCBO · Traditional Chemetron Medical Products, Inc.01/22/1979SE

More from Chemetron Medical Products, Inc.

510(k)DeviceDecision
K760220Tubing, Single Use Oxygen SupplyBYX · Traditional 08/03/1976SE
K760219Maska, Oxygen Vinyl D-Sp. Single UseBYG · Traditional 08/03/1976SE
K760218Cannulae, Plastic Disposable NasalCAT · Traditional 08/03/1976SE

Questions and answers

When was I.P.P.B., Dis. W/Manifold/Nebulizer cleared by the FDA?

I.P.P.B., Dis. W/Manifold/Nebulizer (K760221) received a 510(k) decision of Substantially Equivalent on August 3, 1976, 22 days after the submission was received.

What is the product code of K760221?

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