510(k) DEN140033
- Device
- Companion
- Applicant
- Lgch, Inc.
- 510(k) number
- DEN140033
- Product code
- POS
- Decision
- Unknown (DENG)
- Decision date
- 2017-02-16
- Date received
- 2014-11-10
- Regulation
- 882.1580
- Classification name
- Physiological Signal Based Seizure Monitoring System
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Mike Girouard
- Address
- 115 N Loop, 1604 E.,Suite 1203 San Antonio TX US 78232 78232
FDA Registration Numbers#
- 3042639792
- 3017084392
- 3022175264
- 3043349255
- 3012933969
- 3014886121
Source Documents#
510(k) summary PDF not indicated by FDA
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| K232915 | EpiMonitor | Empatica S.r.l. | 2024-02-15 |
| K200276 | SPEAC System | Brain Sentinel, Inc. | 2021-02-06 |
| K182180 | SPEAC System | Brain Sentinel, Inc. | 2019-05-11 |
| K181861 | Embrace | Empatica S.r.l. | 2018-12-20 |
| K172935 | Embrace | Empatica S.r.l. | 2018-01-26 |