The following data is part of a premarket notification filed by Pro-med Instruments Gmbh with the FDA for Doro Radiolucent Headrest System ( Also Mri-compatible) And Components.
| Device ID | K063494 |
| 510k Number | K063494 |
| Device Name: | DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | PRO-MED INSTRUMENTS GMBH 5450 LEE ST, STE 1 Lehigh Acres, FL 33971 |
| Contact | Edgar Schuele |
| Correspondent | Edgar Schuele PRO-MED INSTRUMENTS GMBH 5450 LEE ST, STE 1 Lehigh Acres, FL 33971 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-20 |
| Decision Date | 2007-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250435534120 | K063494 | 000 |
| 04250435516256 | K063494 | 000 |
| 04250435516249 | K063494 | 000 |
| 04250435516232 | K063494 | 000 |
| 04250435502419 | K063494 | 000 |
| 04250435502402 | K063494 | 000 |
| 04250435502396 | K063494 | 000 |
| 04250435502389 | K063494 | 000 |
| 04250435502310 | K063494 | 000 |
| 04250435502181 | K063494 | 000 |
| 04250435502044 | K063494 | 000 |
| 04250435502037 | K063494 | 000 |
| 04250435502020 | K063494 | 000 |
| 04250435516270 | K063494 | 000 |
| 04250435516287 | K063494 | 000 |
| 04250435520383 | K063494 | 000 |
| 04250435534106 | K063494 | 000 |
| 04250435533987 | K063494 | 000 |
| 04250435533970 | K063494 | 000 |
| 04250435533949 | K063494 | 000 |
| 04250435533932 | K063494 | 000 |
| 04250435532140 | K063494 | 000 |
| 04250435532133 | K063494 | 000 |
| 04250435532072 | K063494 | 000 |
| 04250435520918 | K063494 | 000 |
| 04250435520901 | K063494 | 000 |
| 04250435520420 | K063494 | 000 |
| 04250435520390 | K063494 | 000 |
| 04250435535769 | K063494 | 000 |