K001167 is an FDA 510(k) clearance for the OPI BAND. This device is classified as a Orthosis, Cranial (Class II - Special Controls, product code MVA).
Submitted by Orthomerica Products, Inc. (Washington, US). The FDA issued a Cleared decision on July 7, 2000, 88 days after receiving the submission on April 10, 2000.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5970.
| 510(k) Number | K001167 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2000 |
| Decision Date | July 07, 2000 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | MVA - Orthosis, Cranial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5970 |