FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
K Number: K043075
·
Decision Aug 18, 2005
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
213
Applicant Total
4
Review Days
283
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Basic Information
- Device Name
- TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
- K Number
- K043075
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tenacore Holdings, Inc.
- Date Received
- November 8, 2004
- Decision Date
- August 18, 2005
- 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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