Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-Filter
FDA 510(k) K043120 · Datex-Ohmeda, Inc.
510(k) numberK043120
Submission
- Device name
- Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-Filter
- Applicant
- Datex-Ohmeda, Inc.
Needham, MA, US - Received
- November 12, 2004
- Decision date
- March 1, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 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 |
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Questions and answers
When was Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-Filter cleared by the FDA?
Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-Filter (K043120) received a 510(k) decision of Substantially Equivalent on March 1, 2005, 109 days after the submission was received.
What is the product code of K043120?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.