FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTIUS SYSTEM
K Number: K771151
·
Decision Aug 4, 1977
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
35
Applicant Total
254
Review Days
41
Basic Information
- Device Name
- ARTIUS SYSTEM
- K Number
- K771151
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2960
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- GENERAL ELECTRIC CO.
- Date Received
- June 24, 1977
- Decision Date
- August 4, 1977
- Product Code
- HGL
- 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 |
|---|---|---|---|
| HGL | Transducer, Ultrasonic, Obstetric | FDA class 2 | Obstetrics/Gynecology |
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