510(k) K823194
- Device
- SKIN GALVANOMETER
- Applicant
- SPELSON RESEARCH LABORATORIES, INC.
- 510(k) number
- K823194
- Product code
- HCJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-01-21
- Date received
- 1982-10-26
- Regulation
- 882.1560
- Classification name
- Device, Skin Potential Measurement
- 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
FDA Registration Numbers#
- 3015452693
- 3027605507
- 3017573591
- 3007084556
- 3043657394
- 3017132875
- 3013397886
- 3018070844
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HCJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K832067 | SHARE INT'L TDM | Share Int'L | 1983-10-27 |
Legacy Summary#
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FDA Review#
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