510(k) K840487
- Device
- T-meter
- Applicant
- K.J. ELECTRONICS
- 510(k) number
- K840487
- Product code
- HCS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-03-12
- Date received
- 1984-02-06
- Regulation
- 882.1570
- Classification name
- Device, Temperature Measurement, Direct Contact, Powered
- 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 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 |
| K950986 | NEUROREADER | Artronics | 1995-11-09 |
| K894772 | THERMALGRAPHIC ANALYSER | Medtech Instruments | 1989-10-03 |
| 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 |