FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
BIRTHTRACK (A.K.A. CLM)
K Number: K082704
·
Decision Jan 9, 2009
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
3
Review Days
115
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Basic Information
- Device Name
- BIRTHTRACK (A.K.A. CLM)
- K Number
- K082704
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2800
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Barnev, Ltd.
- Date Received
- September 16, 2008
- Decision Date
- January 9, 2009
- Product Code
- NPB
- Advisory Committee
- Ophthalmic
- 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 |
|---|---|---|---|
| NPB | System, Monitoring, For Progress Of Labor | FDA class 2 | Ophthalmic |
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