FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE
K Number: K922960
·
Decision Nov 5, 1992
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
19
Applicant Total
3
Review Days
140
Basic Information
- Device Name
- VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE
- K Number
- K922960
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.1550
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- CAMEO, INC.
- Date Received
- June 18, 1992
- Decision Date
- November 5, 1992
- 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 |
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