Chrysalis Intelligence · Product Codes · GWJ

GWJ · Stimulator, Auditory, Evoked Response

Neurology · 5 clearances · 4 unique sponsors

Device class
Class II
Regulation 882.1900
Total clearances
5
2020-04-24 → 2024-12-19
Last 12 months
0
Unique sponsors
4
Medical specialty
Neurology
Review panel
NE
Regulation number
882.1900
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Path Medical GmbH 2 0 2022-08-03
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) 1 0 2024-03-08
Grason Stadler 1 0 2020-04-24
Vivosonic, Inc. 1 0 2024-12-19
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
92576 CPT High CPT code for auditory evoked potentials; auditory stimulation for evoked response testing
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2024-12-19 K242954 Vivosonic, Inc. Integrity V500 (Integrity, Integrity with VEMP)
2024-03-08 K233649 Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) ALGO Pro Newborn Hearing Screener (ALGO Pro)
2022-08-03 K220139 Path Medical GmbH QScreen
2021-10-14 K211147 Path Medical GmbH ALGO 7i
2020-04-24 K193033 Grason Stadler GSI Audera Pro