FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
G.E. STERILE AMNIOCENTESIS TRAY
K Number: K960203
·
Decision Mar 14, 1996
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
19
Applicant Total
166
Review Days
58
Basic Information
- Device Name
- G.E. STERILE AMNIOCENTESIS TRAY
- K Number
- K960203
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.1550
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- GE MEDICAL SYSTEMS
- Date Received
- January 16, 1996
- Decision Date
- March 14, 1996
- Product Code
- HIO
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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