FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INNERVISION IRRIGATION PUMP
K Number: K910982
·
Decision Aug 26, 1991
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
4
Review Days
172
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Basic Information
- Device Name
- INNERVISION IRRIGATION PUMP
- K Number
- K910982
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2660
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- M.D. Engineering, Inc.
- Date Received
- March 7, 1991
- Decision Date
- August 26, 1991
- Product Code
- HEI
- 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 |
|---|---|---|---|
| HEI | Monitor, Heart-Valve Movement, Fetal, Ultrasonic | FDA class 2 | Obstetrics/Gynecology |
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