The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Bio Pack Model 200.
| Device ID | K853126 |
| 510k Number | K853126 |
| Device Name: | BIO PACK MODEL 200 |
| Classification | Batteries, Rechargeable, For Class 2 Devices |
| Applicant | BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Contact | John R Dalpee |
| Correspondent | John R Dalpee BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Product Code | MOX |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-25 |
| Decision Date | 1985-10-11 |