FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CART, PROCEDURES
K Number: K770438
·
Decision Jul 1, 1977
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
6
Applicant Total
3
Review Days
116
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Basic Information
- Device Name
- CART, PROCEDURES
- K Number
- K770438
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4900
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- I E Industries
- Date Received
- March 7, 1977
- Decision Date
- July 1, 1977
- Product Code
- HDD
- 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 |
|---|---|---|---|
| HDD | Table, Obstetrical, Ac-Powered (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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