The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Software Modification For Miles H*1 S/w Ver. 1.5.
| Device ID | K920949 |
| 510k Number | K920949 |
| Device Name: | SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5 |
| Classification | Counter, Differential Cell |
| Applicant | HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Contact | Thomas C Brewster |
| Correspondent | Thomas C Brewster HERAEUS KULZER, INC. 511 BENEDICT AVE. Tarrytown, NY 10591 -5097 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-02 |
| Decision Date | 1992-05-15 |