Medical Assemblies Filter

FDA 510(k) K911738 · Medical Assemblies, Inc.

Substantially Equivalent

510(k) numberK911738

Submission

Device name
Medical Assemblies Filter
Applicant
Medical Assemblies, Inc.
Bloomington, IN, US
Received
April 17, 1991
Decision date
July 11, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CAH – Filter, Bacterial, Breathing-Circuit
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5260
Specialty
Anesthesiology

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K241339Besmed Bacterial Filter and HMEFCAH · Traditional Besmed Health Business Corp11/14/2024SE
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K223258TNI Clear-Guard™ 3 angled breathing filter (1545020)CAH · Traditional Intersurgical , Ltd.06/15/2023SE
K221472Filter and HME/FilterCAH · Traditional Ningbo Huakun Medical Equipment Co., Ltd.02/08/2023SE
K221836Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusCAH · Traditional Drägerwerk AG & Co. KGaA12/07/2022SE
K221250EasyOne FilterCAH · Traditional Ndd Medizintechnik AG11/22/2022SE
K210352GGM Breathing Circuit Bacterial FilterCAH · Traditional Great Group Medical Co, Ltd.03/27/2022SE

More from Great Group Medical Co, Ltd.

510(k)DeviceDecision
K911737Medical Assemblies Mass SPECT Monit Line/ConnectCCK · Traditional 07/11/1991SE
K911736Medical Assemblies Adult Anesthesia Breath CircuitCAI · Traditional 07/11/1991SE

Questions and answers

When was Medical Assemblies Filter cleared by the FDA?

Medical Assemblies Filter (K911738) received a 510(k) decision of Substantially Equivalent on July 11, 1991, 85 days after the submission was received.

What is the product code of K911738?

The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.