The following data is part of a premarket notification filed by Hmd Biomedical Inc. with the FDA for Glucoleader Enhance Blood Glucose Monitoring System.
Device ID | K182428 |
510k Number | K182428 |
Device Name: | GlucoLeader Enhance Blood Glucose Monitoring System |
Classification | System, Test, Blood Glucose, Over The Counter |
Applicant | HMD BioMedical Inc. No. 181 Minsheng St., Xinpu Township Hsin Chu County, TW 30542 |
Contact | Jen Ke-min |
Correspondent | Ke-min Jen Chinese-European Industrial Research Society No. 58 Fu-Chiun St. Hsin-chu City, TW 30067 |
Product Code | NBW |
CFR Regulation Number | 862.1345 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-06 |
Decision Date | 2019-05-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04711200722291 | K182428 | 000 |
04711200723922 | K182428 | 000 |
04711200724202 | K182428 | 000 |
04711200724226 | K182428 | 000 |
04711200724240 | K182428 | 000 |
00850048540514 | K182428 | 000 |
00850048540521 | K182428 | 000 |
00810038634746 | K182428 | 000 |
10810038634866 | K182428 | 000 |
00850009854032 | K182428 | 000 |
00850009854049 | K182428 | 000 |
04711200722246 | K182428 | 000 |
04711200723892 | K182428 | 000 |