FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONICAID MODEL P110 FETAL HEAR DETECTOR
K Number: K933816
·
Decision Dec 22, 1994
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
6
Applicant Total
5
Review Days
505
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Basic Information
- Device Name
- SONICAID MODEL P110 FETAL HEAR DETECTOR
- K Number
- K933816
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Oxford Instruments, Plc.
- Date Received
- August 4, 1993
- Decision Date
- December 22, 1994
- 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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