The following data is part of a premarket notification filed by Pro Med Instruments Gmbh with the FDA for Doro Qr3 Xtom Headholder System.
| Device ID | K191979 |
| 510k Number | K191979 |
| Device Name: | DORO QR3 XTom Headholder System |
| Classification | Holder, Head, Neurosurgical (skull Clamp) |
| Applicant | Pro Med Instruments GmbH Boetzinger Str. 38 Freiburg, DE 79111 |
| Contact | Sandra Untenberger |
| Correspondent | Sandra Untenberger Pro Med Instruments GmbH Boetzinger 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 | 2019-07-24 |
| Decision Date | 2019-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250435504024 | K191979 | 000 |
| 04250435535370 | K191979 | 000 |
| 04250435535349 | K191979 | 000 |
| 04250435534649 | K191979 | 000 |
| 04250435532805 | K191979 | 000 |