510(k) K103362
K103362 is an FDA 510(k) premarket notification submitted by Advanced Orthopro, Inc. for the device "AOI CRANIAL HELMET". The FDA issued a decision of Substantially Equivalent on April 18, 2011. The device falls under product code MVA (Orthosis, Cranial), a Class II device regulated under 21 CFR 882.5970.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 2011
- Date Received
- November 17, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Cranial
- Device Class
- Class II
- Regulation Number
- 882.5970
- Review Panel
- NE
- Submission Type