The following data is part of a premarket notification filed by Applied Biomedical Llc with the FDA for Confidence Blood Glucose Monitoring System.
| Device ID | K173658 |
| 510k Number | K173658 |
| Device Name: | Confidence Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Applied Biomedical LLC 1981 E Miraloma Ave., Unit B Placentia, CA 92870 |
| Contact | Zakir Murtaza |
| Correspondent | Jigar Shah mdi Consultants, Inc. 55 Northern Blvd Suite 200 Great Neck, NY 11426 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-29 |
| Decision Date | 2018-08-21 |