The following data is part of a premarket notification filed by Smart Medical Systems, Ltd. with the FDA for Naviaid Icvi-f Device, Naviaid Icvi-s Device, Naviaid Icvi-b Device.
Device ID | K110291 |
510k Number | K110291 |
Device Name: | NAVIAID ICVI-F DEVICE, NAVIAID ICVI-S DEVICE, NAVIAID ICVI-B DEVICE |
Classification | Endoscope Channel Accessory |
Applicant | SMART MEDICAL SYSTEMS, LTD. 10 HAYETSIRA STREET Raanana, IL 43663 |
Contact | Adva Yoselzon |
Correspondent | Adva Yoselzon SMART MEDICAL SYSTEMS, LTD. 10 HAYETSIRA STREET Raanana, IL 43663 |
Product Code | ODC |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-02-01 |
Decision Date | 2011-06-17 |
Summary: | summary |