The following data is part of a premarket notification filed by Sierra Scientific Instruments, Inc. with the FDA for Motility Visualization System.
| Device ID | K031169 |
| 510k Number | K031169 |
| Device Name: | MOTILITY VISUALIZATION SYSTEM |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | SIERRA SCIENTIFIC INSTRUMENTS, INC. 16787 BERNARDO CENTER DR. SUITE A-1 San Diego, CA 92128 |
| Contact | Sean M Curry |
| Correspondent | Sean M Curry SIERRA SCIENTIFIC INSTRUMENTS, INC. 16787 BERNARDO CENTER DR. SUITE A-1 San Diego, CA 92128 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-14 |
| Decision Date | 2003-12-12 |
| Summary: | summary |