The following data is part of a premarket notification filed by Capsovision, Inc. with the FDA for Capsocam Plus (sv-3) Capsule Endoscopy System.
| Device ID | K192662 |
| 510k Number | K192662 |
| Device Name: | CapsoCam Plus (SV-3) Capsule Endoscopy System |
| Classification | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Applicant | CapsoVision, Inc. 18805 Cox Avenue Suite 250 Saratoga, CA 95070 |
| Contact | Azimun Jamal |
| Correspondent | Azimun Jamal CapsoVision, Inc. 18805 Cox Avenue 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 | 2019-09-25 |
| Decision Date | 2020-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867770000223 | K192662 | 000 |
| 00867770000261 | K192662 | 000 |