The following data is part of a premarket notification filed by Synectics-dantec with the FDA for Ambul. Ph & Motility Recorder For Measure Of Para..
| Device ID | K880581 |
| 510k Number | K880581 |
| Device Name: | AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA. |
| Classification | System, Gastrointestinal Motility (electrical) |
| 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 | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-10 |
| Decision Date | 1988-08-11 |