FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POCKET SIZE FETAL HEART DETECTOR
K Number: K920056
·
Decision Dec 11, 1992
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
59
Applicant Total
3
Review Days
340
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Basic Information
- Device Name
- POCKET SIZE FETAL HEART DETECTOR
- K Number
- K920056
- 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 Accessories, Inc.
- Date Received
- January 6, 1992
- Decision Date
- December 11, 1992
- Product Code
- KNG
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- RA
- 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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