The following data is part of a premarket notification filed by The Smartpill Corporation with the FDA for Smartpill Gi Monitoring System, Version 2.0.
| Device ID | K092342 |
| 510k Number | K092342 |
| Device Name: | SMARTPILL GI MONITORING SYSTEM, VERSION 2.0 |
| Classification | Gastrointestinal Motility System, Capsule |
| Applicant | THE SMARTPILL CORPORATION 847 MAIN ST. Buffalo, NY 14203 -1109 |
| Contact | Kathleen Selover |
| Correspondent | Kathleen Selover THE SMARTPILL CORPORATION 847 MAIN ST. Buffalo, NY 14203 -1109 |
| Product Code | NYV |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-04 |
| Decision Date | 2009-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290101367390 | K092342 | 000 |
| 04260167482682 | K092342 | 000 |
| 04260167482705 | K092342 | 000 |
| 04260167482712 | K092342 | 000 |
| 04260167482873 | K092342 | 000 |
| 04260167482880 | K092342 | 000 |
| 04260167482897 | K092342 | 000 |
| 04260167482903 | K092342 | 000 |
| 04260167483573 | K092342 | 000 |
| 07290110360481 | K092342 | 000 |