The following data is part of a premarket notification filed by Burron Medical Products, Inc. with the FDA for Medifix Graduated Scale.
| Device ID | K813195 |
| 510k Number | K813195 |
| Device Name: | MEDIFIX GRADUATED SCALE |
| Classification | Manometer, Blood-pressure, Venous |
| Applicant | BURRON MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRK |
| CFR Regulation Number | 870.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-12 |
| Decision Date | 1981-12-29 |