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 |