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 |