The following data is part of a premarket notification filed by Pronia Medical System, Llc with the FDA for Glucocare Intensive Glycemic Control System.
| Device ID | K081388 |
| 510k Number | K081388 |
| Device Name: | GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM |
| Classification | Calculator, Drug Dose |
| Applicant | PRONIA MEDICAL SYSTEM, LLC 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolte |
| Correspondent | Cynthia J.m. Nolte PRONIA MEDICAL SYSTEM, LLC 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-19 |
| Decision Date | 2008-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G111GCR2 | K081388 | 000 |