FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DANMAR PRODUCTS MICHIGAN CRANIAL HELMET
K Number: K003630
·
Decision May 29, 2001
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
42
Applicant Total
3
Review Days
186
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Basic Information
- Device Name
- DANMAR PRODUCTS MICHIGAN CRANIAL HELMET
- K Number
- K003630
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5970
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Danmar Products, Inc.
- Date Received
- November 24, 2000
- Decision Date
- May 29, 2001
- Product Code
- MVA
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MVA | Orthosis, Cranial | FDA class 2 | Neurology |
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