510(k) K770678
- Device
- ELC-THERMO-SYSTEM
- Applicant
- Cutter Laboratories, Inc.
- 510(k) number
- K770678
- Product code
- KXZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-05-25
- Date received
- 1977-04-11
- Regulation
- 884.2982
- Classification name
- System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 3
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KXZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K851034 | NOVATHERM | Medtech Products, Inc. | 1985-09-27 |
| 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 |