The following data is part of a premarket notification filed by Ppg Industries, Inc. with the FDA for Xr Model H Physiological Monitor & Recording Sys..
| Device ID | K901514 |
| 510k Number | K901514 |
| Device Name: | XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS. |
| Classification | Computer, Blood-pressure |
| Applicant | PPG INDUSTRIES, INC. 9910 WIDMER DR. Lenexa, KS 66215 |
| Contact | Gregory A Whitney |
| Correspondent | Gregory A Whitney PPG INDUSTRIES, INC. 9910 WIDMER DR. Lenexa, KS 66215 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-30 |
| Decision Date | 1990-11-16 |