FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
K Number: K900908
·
Decision May 21, 1990
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
55
Applicant Total
376
Review Days
83
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Basic Information
- Device Name
- CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200
- K Number
- K900908
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1700
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Zimmer, Inc.
- Date Received
- February 27, 1990
- Decision Date
- May 21, 1990
- Product Code
- HIG
- 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 |
|---|---|---|---|
| HIG | Insufflator, Hysteroscopic | FDA class 2 | Obstetrics/Gynecology |
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