The following data is part of a premarket notification filed by Capsovision, Inc with the FDA for Capsocam Plus (sv-3) Capsule Endoscope System.
| Device ID | K161773 |
| 510k Number | K161773 |
| Device Name: | CapsoCam Plus (SV-3) Capsule Endoscope System |
| 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 | 2016-06-28 |
| Decision Date | 2016-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867770000230 | K161773 | 000 |
| 00867770000216 | K161773 | 000 |
| 00867770000209 | K161773 | 000 |