510(k) K013458
K013458 is an FDA 510(k) premarket notification submitted by Children'S Hospital for the device "CRANIAL HELMET". The FDA issued a decision of Substantially Equivalent on Oct 29, 2001. 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
- Oct 29, 2001
- Date Received
- Oct 18, 2001
- 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
- 510(k)