K041215 is an FDA 510(k) clearance for the CRANIAL HELMET. This device is classified as a Orthosis, Cranial (Class II - Special Controls, product code MVA).
Submitted by Otto Bock Healthcare LP (Minneapolis, US). The FDA issued a Cleared decision on September 9, 2004, 122 days after receiving the submission on May 10, 2004.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5970.
| 510(k) Number | K041215 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2004 |
| Decision Date | September 09, 2004 |
| Days to Decision | 122 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 |