The following data is part of a premarket notification filed by Capsovision, Inc. with the FDA for Capsocam Plus (sv-3).
Device ID | K183192 |
510k Number | K183192 |
Device Name: | CapsoCam Plus (SV-3) |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-11-19 |
Decision Date | 2019-04-19 |