Identity
- Trade Name
- QScreen Set FDA UDI
- Generic Name
- Evoked-potential audiometer FDA UDI
- Device Name
- Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station QScreen P/N 101023 EP-LT P/N 101043 Accessory box EP-LT (AB-LT01) P/N 101205 Electrode cable with mini clips or 101256 Electrode cable with crocodile clips P/N 100465-QScreen FW ASSR P/N 100414-QScreen FW Labelprinter P/N 100468 Electrodes, bag of 30 pcs. P/N 101250-12W-NEO Power Supply P/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual english FDA UDI
- Model / Reference
- 101275-AS-EP FDA UDI
- Description
- Set consisting of: P/N 101249 or 101249-17 Carrying Bag QScreen P/N 101199 QScreen P/N 101253 Docking Station QScreen P/N 101023 EP-LT P/N 101043 Accessory box EP-LT (AB-LT01) P/N 101205 Electrode cable with mini clips or 101256 Electrode cable with crocodile clips P/N 100465-QScreen FW ASSR P/N 100414-QScreen FW Labelprinter P/N 100468 Electrodes, bag of 30 pcs. P/N 101250-12W-NEO Power Supply P/N 101251-USA Power Supply Adapter P/N 101203-EN QScreen Manual english FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260223147289 FDA UDI
- 510(k) Number
- K220139 FDA UDI
- FDA Product Code
- GWJ FDA UDI
- GMDN Term
- Evoked-potential audiometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Evoked-potential audiometer
QScreen Set by PATH medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Evoked-potential audiometer.
- ECochG Adapters — Vivosonic Inc · Class II
- TE Tip Sample Box — Otodynamics · Class II
- Tip Sample Box (Neonate) — Otodynamics · Class II
- Otoport LCD service kit — Otodynamics · Class II
- TEOAE probe tips — Otodynamics · Class II
- ABR Case service kit - Top — Otodynamics · Class II
- Otoport ABR Binaural Upgrade Kit (TE) — Otodynamics · Class II
- ABR Test Cavity — Otodynamics · Class II
Cleared under the same submission
K220139 also covers:
- QScreen Set — PATH medical GmbH
- QScreen Set — PATH medical GmbH
- QScreen Set — PATH medical GmbH
- QScreen Set — PATH medical GmbH
- QScreen Set — PATH medical GmbH
- QScreen Set — PATH medical GmbH
- QScreen Set — PATH medical GmbH
- QScreen Set — PATH medical GmbH
- QScreen Set — PATH medical GmbH
- QScreen Set — PATH medical GmbH
- QScreen Set — PATH medical GmbH
- QScreen Set — PATH medical GmbH
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- PATH medical GmbH
Sources (1)
- FDA UDI 07f95fea-c8d4-4cd6-b7e5-efb1ad8932ef 34 fields · synced Jun 8, 2026