Statpal Blood Gas Monitoring System
FDA 510(k) K903965 · Ppg Industries, Inc.
510(k) numberK903965
Submission
- Device name
- Statpal Blood Gas Monitoring System
- Applicant
- Ppg Industries, Inc.
La Jolla, CA, US - Received
- August 28, 1990
- Decision date
- December 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1120
- Specialty
- Clinical Chemistry
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More from Opti Medical Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922631 | Statpal II Blood Gas Analysis SystemCHL · Traditional | 11/10/1992SE |
| K913358 | Midas System(Tm) 5100 Physiolog Monit/Record SystDXG · Traditional | 12/20/1991SE |
| K914560 | Stat Pal Sensyr Syringe Assembly for Use W/StatpalCHL · Traditional | 11/29/1991SE |
| K912627 | Midas System 2500, Physiological Monitoring SystemMHX · Traditional | 09/10/1991SE |
| 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 |
| K896442 | PPG Biomedical Ventilator Model IrisaCBK · Traditional | 04/16/1990SE |
| K900700 | Smu 611 UniversalmonitorDPS · Traditional | 04/03/1990SE |
| K890875 | Cardiotest EK53/EK53R, Cardiognost EK56/EK512DPS · Traditional | 10/17/1989SE |
Questions and answers
When was Statpal Blood Gas Monitoring System cleared by the FDA?
Statpal Blood Gas Monitoring System (K903965) received a 510(k) decision of Substantially Equivalent on December 26, 1990, 120 days after the submission was received.
What is the product code of K903965?
The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.