The following data is part of a premarket notification filed by Medical Decisions Network with the FDA for Clarian Glucose Stabilizer Insulin Dosing Calculator.
| Device ID | K071713 |
| 510k Number | K071713 |
| Device Name: | CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR |
| Classification | Calculator, Drug Dose |
| Applicant | MEDICAL DECISIONS NETWORK 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan Kahan |
| Correspondent | Jonathan Kahan MEDICAL DECISIONS NETWORK 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-22 |
| Decision Date | 2007-10-12 |
| Summary: | summary |