K902206 is an FDA 510(k) clearance for the CONTROL 1 ENVIRONMENTAL CONTROL. This device is classified as a System, Communication, Powered (Class II - Special Controls, product code ILQ).
Submitted by Prentke Romich Co. (Wooster, US). The FDA issued a Cleared decision on May 29, 1990, 13 days after receiving the submission on May 16, 1990.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3710.
| 510(k) Number | K902206 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 1990 |
| Decision Date | May 29, 1990 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ILQ — System, Communication, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3710 |