Precison Thermoplastic Components Gas Ampling Lines and Connectors
FDA 510(k) K943874 · Precision Thermoplastic Components, Inc.
510(k) numberK943874
Submission
- Device name
- Precison Thermoplastic Components Gas Ampling Lines and Connectors
- Applicant
- Precision Thermoplastic Components, Inc.
Lima, OH, US - Received
- August 8, 1994
- Decision date
- October 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K241339 | Besmed Bacterial Filter and HMEFCAH · Traditional | Besmed Health Business Corp | 11/14/2024SE |
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| 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 |
|---|---|---|
| K944429 | Precision Thermoplastic Componenets, Inc. TubingCAI · Traditional | 11/18/1994SE |
Questions and answers
When was Precison Thermoplastic Components Gas Ampling Lines and Connectors cleared by the FDA?
Precison Thermoplastic Components Gas Ampling Lines and Connectors (K943874) received a 510(k) decision of Substantially Equivalent on October 28, 1994, 81 days after the submission was received.
What is the product code of K943874?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.