The following data is part of a premarket notification filed by Gri Medical Products, Inc. with the FDA for Gri Lasergraph(tm) Ecg Paper.
| Device ID | K902586 |
| 510k Number | K902586 |
| Device Name: | GRI LASERGRAPH(TM) ECG PAPER |
| Classification | Recorder, Paper Chart |
| Applicant | GRI MEDICAL PRODUCTS, INC. P.O. BOX 601 Norwalk, CT 06852 |
| Contact | Stephen B Snider |
| Correspondent | Stephen B Snider GRI MEDICAL PRODUCTS, INC. P.O. BOX 601 Norwalk, CT 06852 |
| Product Code | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-12 |
| Decision Date | 1990-06-22 |