FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FETAL & MATERNAL MONITOR, MODEL F6, F9
K Number: K082602
·
Decision Nov 26, 2008
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
210
Applicant Total
47
Review Days
79
Basic Information
- Device Name
- FETAL & MATERNAL MONITOR, MODEL F6, F9
- K Number
- K082602
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EDAN INSTRUMENTS, INC.
- Date Received
- September 8, 2008
- Decision Date
- November 26, 2008
- 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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