FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
MICRO-ARTHROSCOPE
K Number: K930084
·
Decision Sep 1, 1995
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
49
Review Days
967
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Basic Information
- Device Name
- MICRO-ARTHROSCOPE
- K Number
- K930084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Medical Devices, Inc.
- Date Received
- January 7, 1993
- Decision Date
- September 1, 1995
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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| K930053 | VIDEO CAMERA W/ ELECTRONIC SHUTTER MODEL VCE-10 | May 17, 1993 | Substantially Equivalent |
| K923914 | IF-II (TM), MODEL 7200 | Nov 6, 1992 | Substantially Equivalent |
| K920071 | MEDITRON AUTOMATIC ELECTRONIC INSUFF. MODEL AEI-15 | Jul 21, 1992 | Substantially Equivalent |
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