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 |