The following data is part of a premarket notification filed by Ppg Industries, Inc. with the FDA for Statpal Blood Gas Monitoring System.
| Device ID | K903965 |
| 510k Number | K903965 |
| Device Name: | STATPAL BLOOD GAS MONITORING SYSTEM |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | PPG INDUSTRIES, INC. 11077 N. TORREY PINES RD. La Jolla, CA 92037 |
| Contact | Vincent Cutarelli |
| Correspondent | Vincent Cutarelli PPG INDUSTRIES, INC. 11077 N. TORREY PINES RD. La Jolla, CA 92037 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-28 |
| Decision Date | 1990-12-26 |