Stat Pal Sensyr Syringe Assembly for Use W/Statpal
FDA 510(k) K914560 · Ppg Industries, Inc.
510(k) numberK914560
Submission
- Device name
- Stat Pal Sensyr Syringe Assembly for Use W/Statpal
- Applicant
- Ppg Industries, Inc.
La Jolla, CA, US - Received
- October 15, 1991
- Decision date
- November 29, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| 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 Stat Pal Sensyr Syringe Assembly for Use W/Statpal cleared by the FDA?
Stat Pal Sensyr Syringe Assembly for Use W/Statpal (K914560) received a 510(k) decision of Substantially Equivalent on November 29, 1991, 45 days after the submission was received.
What is the product code of K914560?
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.