FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATALOG NUMBER 2609 LEG PLATE
K Number: K905295
·
Decision Feb 19, 1991
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
210
Applicant Total
136
Review Days
84
Basic Information
- Device Name
- CATALOG NUMBER 2609 LEG PLATE
- K Number
- K905295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
- Date Received
- November 27, 1990
- Decision Date
- February 19, 1991
- Product Code
- HGM
- 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 |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | FDA class 2 | Obstetrics/Gynecology |
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