510(k) K851034
- Device
- NOVATHERM
- Applicant
- MED TECH PRODUCTS, INC.
- 510(k) number
- K851034
- Product code
- KXZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-09-27
- Date received
- 1985-03-13
- Regulation
- 884.2982
- Classification name
- System, Thermographic, Liquid Crystal, Powered (adjunctive Use)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Radiology
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM D APPLER
- Address
- Mcdermott, Will & Emery 1850 K St. NW Washington DC US 20006 20006
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KXZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K843124 | Q-SCAN THERMOGRAPHY SYSTEM | Qmax Medical, Inc. | 1984-11-29 |
| K832731 | BREAST & BODY HEALTH SYSTEM 2000 | American Thermal Instruments, Inc. | 1984-01-30 |
| K813547 | THERMASCAN | Bcd Products, Inc. | 1982-03-12 |
| K781916 | FLEXT-THERM | E-Z-Em, Inc. | 1979-02-02 |
| K770986 | FLEXI-THERM FILM | E-Z-Em, Inc. | 1977-09-12 |
| K770678 | ELC-THERMO-SYSTEM | Cutter Laboratories, Inc. | 1977-05-25 |
Legacy Summary#
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FDA Review#
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