The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon On Call Diabetes Management Software.
| Device ID | K131469 |
| 510k Number | K131469 |
| Device Name: | ACON ON CALL DIABETES MANAGEMENT SOFTWARE |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ACON LABORATORIES, INC. 10125 MESA RIM ROAD San Diego, CA 92121 |
| Contact | Qiyi Xie |
| Correspondent | Qiyi Xie ACON LABORATORIES, INC. 10125 MESA RIM ROAD San Diego, CA 92121 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-21 |
| Decision Date | 2014-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00682607001118 | K131469 | 000 |