FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
K Number: K010920
·
Decision Jun 22, 2001
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
6
Applicant Total
3
Review Days
87
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Basic Information
- Device Name
- TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
- K Number
- K010920
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Cables, Inc.
- Date Received
- March 27, 2001
- Decision Date
- June 22, 2001
- Product Code
- HEL
- 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 |
|---|---|---|---|
| HEL | Monitor, Heart Rate, Fetal, Ultrasonic | FDA class 2 | Obstetrics/Gynecology |
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