FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MER MULTIPLANE VAGINAL PROBE (MVP)
K Number: K901142
·
Decision Aug 22, 1990
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
35
Applicant Total
2
Review Days
163
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Basic Information
- Device Name
- MER MULTIPLANE VAGINAL PROBE (MVP)
- K Number
- K901142
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2960
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Medical Equipment Resources
- Date Received
- March 12, 1990
- Decision Date
- August 22, 1990
- Product Code
- HGL
- 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 |
|---|---|---|---|
| HGL | Transducer, Ultrasonic, Obstetric | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Medical Equipment Resources
| K Number | Device Name | ||
|---|---|---|---|
| K901033 | MER MULTIPLANE RECTAL PROBE (MRP) | Aug 22, 1990 | Substantially Equivalent |