PPG Biomedical Ventilator Model Irisa
FDA 510(k) K896442 · Ppg Industries, Inc.
510(k) numberK896442
Submission
- Device name
- PPG Biomedical Ventilator Model Irisa
- Applicant
- Ppg Industries, Inc.
Pleasantville, NY, US - Received
- November 9, 1989
- Decision date
- April 16, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K912627 | Midas System 2500, Physiological Monitoring SystemMHX · Traditional | 09/10/1991SE |
| K903965 | Statpal Blood Gas Monitoring SystemCHL · Traditional | 12/26/1990SE |
| K901514 | XR Model H Physiological Monitor & Recording Sys.DSK · Traditional | 11/16/1990SE |
| K900246 | Cardiotest Ek 53 R, Cardiognost Ek 56/ Ek 512DSI · Traditional | 07/03/1990SE |
| K901132 | Sara SatcapCCK · Traditional | 05/22/1990SE |
| K900700 | Smu 611 UniversalmonitorDPS · Traditional | 04/03/1990SE |
| K890875 | Cardiotest EK53/EK53R, Cardiognost EK56/EK512DPS · Traditional | 10/17/1989SE |
Questions and answers
When was PPG Biomedical Ventilator Model Irisa cleared by the FDA?
PPG Biomedical Ventilator Model Irisa (K896442) received a 510(k) decision of Substantially Equivalent on April 16, 1990, 158 days after the submission was received.
What is the product code of K896442?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.