FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FETAL PULSE DETECTORS, F50/F60
K Number: K812868
·
Decision Nov 25, 1981
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
59
Applicant Total
1
Review Days
42
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Basic Information
- Device Name
- FETAL PULSE DETECTORS, F50/F60
- K Number
- K812868
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- South Carolina Medical, Inc.
- Date Received
- October 14, 1981
- Decision Date
- November 25, 1981
- Product Code
- KNG
- 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 |
|---|---|---|---|
| KNG | Monitor, Ultrasonic, Fetal | FDA class 2 | Obstetrics/Gynecology |
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