The following data is part of a premarket notification filed by Grass-telefactor Product Group with the FDA for Modac-xxxx Intensive Monitoring Of Eeg.
| Device ID | K860128 |
| 510k Number | K860128 |
| Device Name: | MODAC-XXXX INTENSIVE MONITORING OF EEG |
| Classification | Encephalogram Telemetry System |
| Applicant | GRASS-TELEFACTOR PRODUCT GROUP UNION HILL BLDG., DEHAVEN ST. W. Conshohocken, PA 19428 |
| Contact | John Chatten |
| Correspondent | John Chatten GRASS-TELEFACTOR PRODUCT GROUP UNION HILL BLDG., DEHAVEN ST. W. Conshohocken, PA 19428 |
| Product Code | GYE |
| CFR Regulation Number | 882.1855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-14 |
| Decision Date | 1986-03-27 |