510(k) K950986
- Device
- NEUROREADER
- Applicant
- ARTRONICS
- 510(k) number
- K950986
- Product code
- HCS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-11-09
- Date received
- 1995-03-03
- Regulation
- 882.1570
- Classification name
- Device, Temperature Measurement, Direct Contact, Powered
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT A TEAGUE
- Address
- 464 Sweetbriar Way Easley SC US 29640 29640
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HCS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K981805 | POS T-7000 | Pos Technologies, Inc. | 1998-08-07 |
| K974208 | TYTRON C-3000 | Titronics Research & Development Co. | 1998-02-03 |
| K894772 | THERMALGRAPHIC ANALYSER | Medtech Instruments | 1989-10-03 |
| K840487 | T-METER | K.J. Electronics | 1984-03-12 |
| K831995 | TRENDO-SCOPE | Gabriel Ent. | 1983-08-08 |
| K822795 | GABRIEL DIGITREND | Gabriel Ent. | 1982-10-08 |
| K821107 | EXOPHTHALMOMETER | Medical Equipment Designs, Inc. | 1982-06-14 |
Legacy Summary#
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FDA Review#
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