The following data is part of a premarket notification filed by Dr. Bruno Lange Gmbh with the FDA for Flame Photometers.
| Device ID | K834226 |
| 510k Number | K834226 |
| Device Name: | FLAME PHOTOMETERS |
| Classification | Flame Emission Photometer For Clinical Use |
| Applicant | DR. BRUNO LANGE GMBH 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JJO |
| CFR Regulation Number | 862.2540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-06 |
| Decision Date | 1984-06-22 |