FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURECALL EMG LABOR MONITOR
K Number: K090145
·
Decision Jan 25, 2011
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
9
Applicant Total
2
Review Days
734
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Basic Information
- Device Name
- SURECALL EMG LABOR MONITOR
- K Number
- K090145
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Reproductive Research Technologies, LP
- Date Received
- January 21, 2009
- Decision Date
- January 25, 2011
- Product Code
- OSP
- 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 |
|---|---|---|---|
| OSP | Uterine Electromyographic Monitor | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Reproductive Research Technologies, LP
| K Number | Device Name | ||
|---|---|---|---|
| K130002 | SURECALL LABOR MONITOR | Jun 28, 2013 | Substantially Equivalent |