FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEALTHSTAR ELITE
K Number: K043239
·
Decision Dec 22, 2004
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
70
Applicant Total
17
Review Days
29
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Basic Information
- Device Name
- HEALTHSTAR ELITE
- K Number
- K043239
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5900
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hill Laboratories Co.
- Date Received
- November 23, 2004
- Decision Date
- December 22, 2004
- Product Code
- ITH
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ITH | Equipment, Traction, Powered | FDA class 2 | Physical Medicine |
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