The following data is part of a premarket notification filed by Medical Decision Network with the FDA for Glucostabilizer Insulin Dosing Calculator.
| Device ID | K141321 |
| 510k Number | K141321 |
| Device Name: | GLUCOSTABILIZER INSULIN DOSING CALCULATOR |
| Classification | Calculator, Drug Dose |
| Applicant | MEDICAL DECISION NETWORK 2657 CORALBERRY PL Charlottesville, VA 22911 |
| Contact | Jane Keathley |
| Correspondent | Jane Keathley MEDICAL DECISION NETWORK 2657 CORALBERRY PL Charlottesville, VA 22911 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-20 |
| Decision Date | 2014-09-15 |
| Summary: | summary |