510(k) K830325
- Device
- Tiger Pulse
- Applicant
- BERTONE & ASSOC.
- 510(k) number
- K830325
- Product code
- GZK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-01
- Date received
- 1983-02-01
- Regulation
- 882.1340
- Classification name
- Electrode, Nasopharyngeal
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GZK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K030517 | BALL RECORDING ELECTRODE/STIMULATION PROBE | Viasys Healthcare, Inc. | 2003-08-01 |