The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Blood Glucose Monitor.
| Device ID | K834099 |
| 510k Number | K834099 |
| Device Name: | BLOOD GLUCOSE MONITOR |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | HEALTHDYNE, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-28 |
| Decision Date | 1984-02-03 |