The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Medisense Pen 2/companion 2 Blood Glucose System.
| Device ID | K901613 |
| 510k Number | K901613 |
| Device Name: | MEDISENSE PEN 2/COMPANION 2 BLOOD GLUCOSE SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | MEDISENSE, INC. 128 SIDNEY ST. Cambridge, MA 02139 |
| Contact | Lias, Ph.d. |
| Correspondent | Lias, Ph.d. MEDISENSE, INC. 128 SIDNEY ST. Cambridge, MA 02139 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-06 |
| Decision Date | 1990-07-10 |