The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Pc Polygraf.
| Device ID | K872712 |
| 510k Number | K872712 |
| Device Name: | PC POLYGRAF |
| Classification | Monitor, Esophageal Motility, And Tube |
| Applicant | SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving, TX 75038 |
| Contact | Maria Lendau |
| Correspondent | Maria Lendau SYNECTICS-DANTEC 1425 GREENWAY DR. SUITE 600 Irving, TX 75038 |
| Product Code | KLA |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-10 |
| Decision Date | 1988-03-18 |