Non-Reusable Universal Nebulizer Filte
FDA 510(k) K823257 · Ohio Medical Products
510(k) numberK823257
Submission
- Device name
- Non-Reusable Universal Nebulizer Filte
- Applicant
- Ohio Medical Products
Mchenry, IL, US - Received
- November 1, 1982
- Decision date
- December 9, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledCAH · Traditional | Teleflex Medical Sdn. Bhd. | 05/15/2026SE |
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| K241339 | Besmed Bacterial Filter and HMEFCAH · Traditional | Besmed Health Business Corp | 11/14/2024SE |
| K222917 | Breathing circuit bacterial/viral filterCAH · Traditional | Shaoxing Haitech Medical Products Co., Ltd. | 02/15/2024SE |
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)CAH · Traditional | Passy-Muir, Inc. | 09/16/2023SE |
| K223258 | TNI Clear-Guard 3 angled breathing filter (1545020)CAH · Traditional | Intersurgical , Ltd. | 06/15/2023SE |
| K221472 | Filter and HME/FilterCAH · Traditional | Ningbo Huakun Medical Equipment Co., Ltd. | 02/08/2023SE |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusCAH · Traditional | Drägerwerk AG & Co. KGaA | 12/07/2022SE |
| K221250 | EasyOne FilterCAH · Traditional | Ndd Medizintechnik AG | 11/22/2022SE |
| K210352 | GGM Breathing Circuit Bacterial FilterCAH · Traditional | Great Group Medical Co, Ltd. | 03/27/2022SE |
More from Great Group Medical Co, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K841733 | Ohio Waste Gas Scavenging ReservoirCBN · Traditional | 07/11/1984SE |
| K842003 | Ohio Waste Gas Scavenging InterfaceCBN · Traditional | 05/23/1984SE |
| K840356 | Ohio Unitrol II Anesthesia Gas MachineBSZ · Traditional | 04/20/1984SE |
| K841274 | Bag-To-Ventilator Selector ValveBSZ · Traditional | 04/13/1984SE |
| K840967 | Ohio Heat Reflecting PatchFMI · Traditional | 03/23/1984SE |
| K840858 | Ohio 3300 Infant Warmer SystemFMT · Traditional | 03/23/1984SE |
| K840857 | Ohio 3000 Infant Warmer SystemFMT · Traditional | 03/23/1984SE |
| K840453 | Medishield PVM RespirometerBZK · Traditional | 03/02/1984SE |
| K840452 | Premium Dabm Dispos. Anes. Breath MaskBSJ · Traditional | 02/17/1984SE |
| K833335 | Modulus II Anesthesia Gas MachineBSZ · Traditional | 11/14/1983SE |
Questions and answers
When was Non-Reusable Universal Nebulizer Filte cleared by the FDA?
Non-Reusable Universal Nebulizer Filte (K823257) received a 510(k) decision of Substantially Equivalent on December 9, 1982, 38 days after the submission was received.
What is the product code of K823257?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.