FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KOALA CLAMP
K Number: K010695
·
Decision May 3, 2001
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
35
Applicant Total
3
Review Days
56
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Basic Information
- Device Name
- KOALA CLAMP
- K Number
- K010695
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maternus, Inc.
- Date Received
- March 8, 2001
- Decision Date
- May 3, 2001
- Product Code
- HFW
- 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 |
|---|---|---|---|
| HFW | Clamp, Umbilical | FDA class 2 | Obstetrics/Gynecology |
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