FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GE SONOCHROME
K Number: K915138
·
Decision Oct 20, 1992
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
8
Applicant Total
169
Review Days
342
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Basic Information
- Device Name
- GE SONOCHROME
- K Number
- K915138
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE Medical Systems
- Date Received
- November 13, 1991
- Decision Date
- October 20, 1992
- Product Code
- MAA
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| MAA | Monitor, Fetal Doppler Ultrasound | FDA class 2 | Obstetrics/Gynecology |
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