Elc-Thermo-System
FDA 510(k) K770678 · Cutter Laboratories, Inc.
510(k) numberK770678
Submission
- Device name
- Elc-Thermo-System
- Applicant
- Cutter Laboratories, Inc.
Walker, MI, US - Received
- April 11, 1977
- Decision date
- May 25, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KXZ – System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 884.2982
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code KXZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K851034 | NovathermKXZ · Traditional | Medtech Products, Inc. | 09/27/1985SE |
| K843124 | Q-Scan Thermography SystemKXZ · Traditional | Qmax Medical, Inc. | 11/29/1984SE |
| K832731 | Breast & Body Health System 2000KXZ · Traditional | American Thermal Instruments, Inc. | 01/30/1984SE |
| K813547 | ThermascanKXZ · Traditional | Bcd Products, Inc. | 03/12/1982SE |
| K781916 | Flext-ThermKXZ · Traditional | E-Z-Em, Inc. | 02/02/1979SE |
| K770986 | Flexi-Therm FilmKXZ · Traditional | E-Z-Em, Inc. | 09/12/1977SE |
More from E-Z-Em, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K861315 | Hyperbaric Penetration Extension SetCBF · Traditional | 05/21/1986SE |
| K854106 | BaysilexELW · Traditional | 03/17/1986SE |
| K842324 | PerfourmELW · Traditional | 11/09/1984SE |
| K834106 | Intravenous Infusion ControllerLDR · Traditional | 05/30/1984SE |
| K832237 | Orthopedic Casting Tape MaxcastITG · Traditional | 08/16/1983SE |
| K823214 | Dosimetric Release Program - Admin. SetFPA · Traditional | 01/12/1983SE |
| K821326 | Cutter Bond Polycarboxylate CementEMA · Traditional | 05/28/1982SE |
| K813532 | Cutterbond Zinc Phosphate CementEMA · Traditional | 03/02/1982SE |
| K802105 | C-BladeHWE · Traditional | 09/16/1980SE |
| K802104 | C-SplintIQI · Traditional | 09/16/1980SE |
Questions and answers
When was Elc-Thermo-System cleared by the FDA?
Elc-Thermo-System (K770678) received a 510(k) decision of Substantially Equivalent on May 25, 1977, 44 days after the submission was received.
What is the product code of K770678?
The FDA product code is KXZ – System, Thermographic, Liquid Crystal, Powered (Adjunctive Use), a Class III (high risk) device regulated under 21 CFR 884.2982.