The following data is part of a premarket notification filed by Branchpoint Technologies, Inc. with the FDA for Aura Icp Monitoring System.
| Device ID | K172209 |
| 510k Number | K172209 |
| Device Name: | AURA ICP MONITORING SYSTEM |
| Classification | Device, Monitoring, Intracranial Pressure |
| Applicant | Branchpoint Technologies, INC. 1 Technology Drive, Suite I-811 Irvine, CA 92618 |
| Contact | Nicholas Hu |
| Correspondent | Nicholas Hu Branchpoint Technologies, INC. 1 Technology Drive, Suite I-811 Irvine, CA 92618 |
| Product Code | GWM |
| CFR Regulation Number | 882.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-24 |
| Decision Date | 2018-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G460TX1010 | K172209 | 000 |
| 00860011785217 | K172209 | 000 |
| 00860011785224 | K172209 | 000 |
| 00860011785231 | K172209 | 000 |
| 00860011785248 | K172209 | 000 |
| 00860011785255 | K172209 | 000 |
| 00860011785262 | K172209 | 000 |
| 00860011785279 | K172209 | 000 |
| 00860011785286 | K172209 | 000 |
| 00860011785293 | K172209 | 000 |
| G460DG1010 | K172209 | 000 |
| G460SP1010 | K172209 | 000 |
| G460TA1010 | K172209 | 000 |
| G460TB1010 | K172209 | 000 |
| G460TC1010 | K172209 | 000 |
| G460TK1010 | K172209 | 000 |
| 00860011785200 | K172209 | 000 |