The following data is part of a premarket notification filed by Ppg Industries, Inc. with the FDA for Smu 611 Universalmonitor.
| Device ID | K900700 |
| 510k Number | K900700 |
| Device Name: | SMU 611 UNIVERSALMONITOR |
| Classification | Electrocardiograph |
| Applicant | PPG INDUSTRIES, INC. 16505 W. 113TH ST. P.O. BOX 15955 Lenexa, KS 66215 |
| Contact | Chris Dedyo |
| Correspondent | Chris Dedyo PPG INDUSTRIES, INC. 16505 W. 113TH ST. P.O. BOX 15955 Lenexa, KS 66215 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-12 |
| Decision Date | 1990-04-03 |