The following data is part of a premarket notification filed by Ceragem Medisys Inc. with the FDA for Glucovitaal H1a Blood Glucose Monitoring System.
| Device ID | K141829 |
| 510k Number | K141829 |
| Device Name: | GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | CERAGEM MEDISYS INC. 16 JEONGJA1-GIL, SEONGGEO-EUP, SEOBUK-GU Cheonan, Chungcheongnam-do, KR 331-833 |
| Contact | Hak-sung Kim |
| Correspondent | Hak-sung Kim CERAGEM MEDISYS INC. 16 JEONGJA1-GIL, SEONGGEO-EUP, SEOBUK-GU Cheonan, Chungcheongnam-do, KR 331-833 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-07 |
| Decision Date | 2014-09-24 |
| Summary: | summary |