The following data is part of a premarket notification filed by Pro-med Instruments Gmbh with the FDA for Doro Headrest System.
| Device ID | K001808 |
| 510k Number | K001808 |
| Device Name: | DORO HEADREST SYSTEM |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | PRO-MED INSTRUMENTS GMBH 9070 BLUFFVIEW TRACE Roswell, GA 30076 |
| Contact | Anita Thibeault |
| Correspondent | Anita Thibeault PRO-MED INSTRUMENTS GMBH 9070 BLUFFVIEW TRACE Roswell, GA 30076 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-15 |
| Decision Date | 2000-08-04 |