The following data is part of a premarket notification filed by Ppg Industries, Inc. with the FDA for Midas System 2500, Physiological Monitoring System.
| Device ID | K912627 |
| 510k Number | K912627 |
| Device Name: | MIDAS SYSTEM 2500, PHYSIOLOGICAL MONITORING SYSTEM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-14 |
| Decision Date | 1991-09-10 |