The following data is part of a premarket notification filed by The Smartpill Corporation with the FDA for Smartpill Gi Monitoring System.
| Device ID | K053547 |
| 510k Number | K053547 |
| Device Name: | SMARTPILL GI MONITORING SYSTEM |
| Classification | Gastrointestinal Motility System, Capsule |
| Applicant | THE SMARTPILL CORPORATION 847 MAIN ST. Buffalo, NY 14203 |
| Contact | Kathleen Selover |
| Correspondent | Kathleen Selover THE SMARTPILL CORPORATION 847 MAIN ST. Buffalo, NY 14203 |
| Product Code | NYV |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-20 |
| Decision Date | 2006-07-18 |
| Summary: | summary |