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 |