The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for Flext-therm.
| Device ID | K781916 |
| 510k Number | K781916 |
| Device Name: | FLEXT-THERM |
| Classification | System, Thermographic, Liquid Crystal, Powered (adjunctive Use) |
| Applicant | E-Z-EM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KXZ |
| CFR Regulation Number | 884.2982 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-14 |
| Decision Date | 1979-02-02 |