Flexi-Therm Film
FDA 510(k) K770986 · E-Z-Em, Inc.
510(k) numberK770986
Submission
- Device name
- Flexi-Therm Film
- Applicant
- E-Z-Em, Inc.
Mchenry, IL, US - Received
- May 31, 1977
- Decision date
- September 12, 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 |
| K770678 | Elc-Thermo-SystemKXZ · Traditional | Cutter Laboratories, Inc. | 05/25/1977SE |
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Questions and answers
When was Flexi-Therm Film cleared by the FDA?
Flexi-Therm Film (K770986) received a 510(k) decision of Substantially Equivalent on September 12, 1977, 104 days after the submission was received.
What is the product code of K770986?
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.