K935981 is an FDA 510(k) clearance for the MLT-2. This device is classified as a System, Communication, Powered (Class II - Special Controls, product code ILQ).
Submitted by Med Labs, Inc. (Goleta, US). The FDA issued a Cleared decision on February 17, 1994, 65 days after receiving the submission on December 14, 1993.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3710.
| 510(k) Number | K935981 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1993 |
| Decision Date | February 17, 1994 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ILQ — System, Communication, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3710 |