One-Way Valve (with Connector)
FDA 510(k) K970780 · Instrumentation Industries, Inc.
510(k) numberK970780
Submission
- Device name
- One-Way Valve (with Connector)
- Applicant
- Instrumentation Industries, Inc.
Bethel Park, PA, US - Received
- March 4, 1997
- Decision date
- September 18, 1997
- 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
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| 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 |
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Questions and answers
When was One-Way Valve (with Connector) cleared by the FDA?
One-Way Valve (with Connector) (K970780) received a 510(k) decision of Substantially Equivalent on September 18, 1997, 198 days after the submission was received.
What is the product code of K970780?
The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.