CPR Micromask
FDA 510(k) K951483 · Plasco, Inc.
510(k) numberK951483
Submission
- Device name
- CPR Micromask
- Applicant
- Plasco, Inc.
Gurnee, IL, US - Received
- March 30, 1995
- Decision date
- October 19, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CBP – Valve, Non-Rebreathing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5870
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code CBP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K980066 | CPR FiltershieldBTM · Traditional | 07/16/1998SE |
| K953414 | CPR Micromask with Oxygen InletCBP · Traditional | 03/20/1996SE |
| K950770 | CPR Microshield IICBP · Traditional | 03/10/1995SE |
| K950769 | CPR Micromask Plus Catalog No 73-402CBP · Traditional | 03/10/1995SE |
| K943386 | CPR MicromaskCBP · Traditional | 02/21/1995SE |
| K932649 | PharmafeedKPE · Traditional | 11/16/1993SE |
| K880337 | Macbick Disposable Barium Enema Syst 4800 & 4700FCE · Traditional | 04/14/1988SE |
| K870623 | Enteral Administration SetFPD · Traditional | 06/26/1987SE |
| K870796 | Macbick-Xl Basic Air Contast Barium Enema Deliv SyFCE · Traditional | 04/01/1987SE |
| K870019 | The Lahr BalloonFCE · Traditional | 04/01/1987SE |
Questions and answers
When was CPR Micromask cleared by the FDA?
CPR Micromask (K951483) received a 510(k) decision of Substantially Equivalent on October 19, 1995, 203 days after the submission was received.
What is the product code of K951483?
The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.