The following data is part of a premarket notification filed by Synectics Medical, Inc. with the FDA for Esophageal Manometry Analysis Module.
| Device ID | K961070 |
| 510k Number | K961070 |
| Device Name: | ESOPHAGEAL MANOMETRY ANALYSIS MODULE |
| Classification | Monitor, Esophageal Motility, Anorectal Motility, And Tube |
| Applicant | SYNECTICS MEDICAL, INC. 1425 GREENWAY DR., #600 Irving, TX 75038 |
| Contact | Anna Pettersson |
| Correspondent | Anna Pettersson SYNECTICS MEDICAL, INC. 1425 GREENWAY DR., #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 | 1996-03-18 |
| Decision Date | 1996-06-11 |
| Summary: | summary |