The following data is part of a premarket notification filed by Capsovision, Inc. with the FDA for Capsocam (sv-1).
| Device ID | K151635 |
| 510k Number | K151635 |
| Device Name: | CapsoCam (SV-1) |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | CapsoVision, Inc. 18805 Cox Ave Suite 250 Saratoga, CA 95070 |
| Contact | Azimun Jamal |
| Correspondent | Azimun Jamal CapsoVision, Inc. 18805 Cox Ave Suite 250 Saratoga, CA 95070 |
| Product Code | NEZ |
| CFR Regulation Number | 876.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-17 |
| Decision Date | 2016-02-09 |
| Summary: | summary |