The following data is part of a premarket notification filed by Pro Med Instruments Gmbh with the FDA for Doro Qr3 Headrest System (aluminum).
| Device ID | K203505 |
| 510k Number | K203505 |
| Device Name: | DORO QR3 Headrest System (Aluminum) |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | pro Med Instruments GmbH Boetziger Str. 38 Freiburg, DE 79111 |
| Contact | Muhammad Zubair |
| Correspondent | Muhammad Zubair pro Med Instruments GmbH Boetziger Str. 38 Freiburg, DE 79111 |
| Product Code | HBL |
| CFR Regulation Number | 882.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-30 |
| Decision Date | 2021-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250435514917 | K203505 | 000 |
| 04250435506196 | K203505 | 000 |
| 04250435500569 | K203505 | 000 |
| 04250435500019 | K203505 | 000 |