The following data is part of a premarket notification filed by Ppg Industries, Inc. with the FDA for Midas System(tm) 5100 Physiolog Monit/record Syst.
| Device ID | K913358 |
| 510k Number | K913358 |
| Device Name: | MIDAS SYSTEM(TM) 5100 PHYSIOLOG MONIT/RECORD SYST |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | PPG INDUSTRIES, INC. 16505 W. 113TH ST. P.O. BOX 15955 Lenexa, KS 66215 |
| Contact | Gregory A Whitney |
| Correspondent | Gregory A Whitney PPG INDUSTRIES, INC. 16505 W. 113TH ST. P.O. BOX 15955 Lenexa, KS 66215 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-29 |
| Decision Date | 1991-12-20 |