510(k) K030517
- Device
- BALL RECORDING ELECTRODE/STIMULATION PROBE
- Applicant
- Viasys Healthcare, Inc.
- 510(k) number
- K030517
- Product code
- GZK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-08-01
- Date received
- 2003-02-19
- Regulation
- 882.1340
- Classification name
- Electrode, Nasopharyngeal
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Gary Syring
- Address
- 800 Levanger Ln. Stoughton WI US 53589 53589
Source Documents#
Other 510(k) Records For Product Code GZK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K830325 | TIGER PULSE | Bertone & Assoc. | 1983-03-01 |