FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA
K Number: K974122
·
Decision Jan 22, 1998
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
90
Applicant Total
1
Review Days
83
Basic Information
- Device Name
- ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA
- K Number
- K974122
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5580
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- SCIENTIFIC HEALTH CARE
- Date Received
- October 31, 1997
- Decision Date
- January 22, 1998
- Product Code
- MQX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| MQX | Needle, Acupuncture, Single Use | FDA class 2 | General Hospital |
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