The following data is part of a premarket notification filed by Ppg Industries, Inc. with the FDA for Rm-301 Patient Monitor.
| Device ID | K880498 |
| 510k Number | K880498 |
| Device Name: | RM-301 PATIENT MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | PPG INDUSTRIES, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
| Contact | Steve Brody |
| Correspondent | Steve Brody PPG INDUSTRIES, INC. ONE CAMPUS DR. Pleasantville, NY 10570 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-05 |
| Decision Date | 1988-05-13 |