The following data is part of a premarket notification filed by Ppg Industries, Inc. with the FDA for Ecg/respiration/arrhythmia Module For Rm-301.
| Device ID | K880505 |
| 510k Number | K880505 |
| Device Name: | ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301 |
| Classification | Detector And Alarm, Arrhythmia |
| 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 | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-05 |
| Decision Date | 1988-12-27 |