945CDAQ916
by Medtronic Sofamor Danek, Inc.
945CDAQ916 is a Class I device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K050798 on 15 Aug 2005 and listed in FDA GUDID since 13 Feb 2018 (UDI-DI 00643169071759), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00643169071759 | Date13 Feb 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK050798 | Date15 Aug 2005 | StatusActive |
Official records
- AccessGUDID record 00643169071759
- FDA 510(k) database K050798
Across registries
- FDA 510(k) K050798 decided 15 Aug 2005 Active
- FDA GUDID UDI-DI 00643169071759 listed 13 Feb 2018 Listed
Timeline
- Cleared FDA 510(k) K050798
- Listed FDA GUDID 00643169071759
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Nerve-locating system
- Model / reference
- 945CDAQ916
- Primary DI / UDI-DI
- 00643169071759
- 510(k) Number
- FDA product code
- GWS, GWF, GWJ, GWE, GWQ
- GMDN term
- Nerve-locating system
- Device class
- Class I
- Regulation number
- 882.1420, 882.1870, 882.1900, 882.1890, 882.1400
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GWS (ANALYZER, SPECTRUM, ELECTROENCEPHALOGRAM SIGNAL).
- PERSYST PRISM by Persyst Development LLC
- ISTAT SOFTWARE by Neuroscience, Inc.
- STD-228 SPECTRAL TREND DISPLAY by Grass-Telefactor Product Group
- CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE by Cns, Inc.
- NEUROMETRICS MONITOR by Neurometrics
- CNS-16 & LTM 1.0 SOFTWARE by Cns, Inc.
- NEUROLAB II by Teca, Inc.
- MINI-CEARS COMPUTER (MODEL 1) by Bik Foundation, Inc.
- NEUROSCIENCE MAP-10 EEG by Neuroscience, Inc.
- OEE_7102 EEG/TREND MONITOR by NIHON KOHDEN AMERICA, INC.