The following data is part of a premarket notification filed by Cortronic Corp. with the FDA for Cortronic Scr1000.
| Device ID | K884911 |
| 510k Number | K884911 |
| Device Name: | CORTRONIC SCR1000 |
| Classification | Recorder, Paper Chart |
| Applicant | CORTRONIC CORP. 105 COMAC ST. Ronkonkoma, NY 11779 |
| Contact | George Munson |
| Correspondent | George Munson CORTRONIC CORP. 105 COMAC ST. Ronkonkoma, NY 11779 |
| Product Code | DSF |
| CFR Regulation Number | 870.2810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-25 |
| Decision Date | 1989-01-13 |