Resuscitator Valve Assembly W/Filter
FDA 510(k) K882204 · Intertech/Ohio
510(k) numberK882204
Submission
- Device name
- Resuscitator Valve Assembly W/Filter
- Applicant
- Intertech/Ohio
Fort Myers, FL, US - Received
- May 25, 1988
- Decision date
- July 8, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBP – Valve, Non-Rebreathing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5870
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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|---|---|---|---|
| K241366 | QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)CBP · Traditional | Dehas Medical Systems GmbH | 10/29/2024SE |
| K234053 | F&P Optiflow Flow DiverterCBP · Traditional | Fisher & Paykel Healthcare, Ltd. | 08/09/2024SE |
| K210992 | Altech® Exhalation Valve (Single Limb and Dual Limb)CBP · Traditional | Meditera Tibbi Malzeme San VE Tic AS | 12/23/2021SE |
| K192285 | CPR Face ShieldCBP · Traditional | Firstar Healthcare Company Limited (Guangzhou) | 11/25/2020SE |
| K173770 | OJR215 Pressure Relief ManifoldCBP · Traditional | Fisher & Paykel Healthcare Limited | 04/05/2019SE |
| K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower…CBP · Traditional | Xiamen Compower Medical Tech. Co., Ltd. | 11/17/2017SE |
| K152521 | Seal Rite Non-Rebreathing ValveCBP · Traditional | The Lifeguard Store, Inc. | 06/03/2016SE |
| K142764 | KYOLING CPR Mask with Oxygen Port and Without Oxygen PortCBP · Traditional | Hangzhou Jinlin Medical Appliances Co., Ltd. | 07/09/2015SE |
| K142402 | BigEasy Non-Rebreathing ValveCBP · Traditional | 12th Man Technologies, Inc. | 03/23/2015SE |
| K132143 | Exhalation ValveCBP · Traditional | Intersurgical Incorporated | 06/04/2014SE |
More from Intersurgical Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K895144 | Intertech Metered Dose ElbowBZA · Traditional | 10/19/1989SE |
| K890346 | Intertech Universal Hydrophobic FilterCAH · Traditional | 03/01/1989SE |
| K884525 | Pediatric Humidifier Tube W/ Temperature PortBZO · Traditional | 12/16/1988SE |
| K884526 | Adult Resuscitator with Mask and FilterBTM · Traditional | 11/16/1988SE |
| K880394 | First Response Pediatric Emergency ResuscitatorBTM · Traditional | 02/29/1988SE |
| K863033 | Patient Gas Sampling KIT/5STAND Alone VersionsBZO · Traditional | 08/20/1986SE |
| K862020 | Heat/Moisture Exchanger, Hme, W/Integral FilterBYD · Traditional | 06/30/1986SE |
| K860650 | 90 Degree Elbow & Straight ConnectorBZA · Traditional | 03/28/1986SE |
| K861056 | Straight Adapt W/Temp Sensing Port/Closure PlugBZA · Traditional | 03/27/1986SE |
Questions and answers
When was Resuscitator Valve Assembly W/Filter cleared by the FDA?
Resuscitator Valve Assembly W/Filter (K882204) received a 510(k) decision of Substantially Equivalent on July 8, 1988, 44 days after the submission was received.
What is the product code of K882204?
The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.