FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTIVIEW
K Number: K972520
·
Decision Sep 29, 1997
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
15
Review Days
84
Basic Information
- Device Name
- OPTIVIEW
- K Number
- K972520
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- OPTIMED TECHNOLOGIES, INC.
- Date Received
- July 7, 1997
- Decision Date
- September 29, 1997
- Product Code
- LLZ
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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| K Number | Device Name | ||
|---|---|---|---|
| K955276 | BOOSTER LITE 4 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K955275 | BOOSTER TROPHY 5 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K955274 | BOOSTER LITE 3 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K943598 | FLEXIBLE FIBER OPTIC LAPAROSCOPES | Oct 18, 1994 | Substantially Equivalent |
| K926597 | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) | Jul 12, 1994 | Substantially Equivalent |
| K921942 | HYSTEROSCOPE (AND ACCESSORIES) | Jun 24, 1994 | Substantially Equivalent |
| K922711 | FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE | May 17, 1994 | Substantially Equivalent |
| K921985 | ARTHROSCOPE & ACCESSORIES | Jun 29, 1993 | Substantially Equivalent |
| K922826 | FLEXIBLE FIBER OPTIC ENDOSCOPE | Feb 19, 1993 | Substantially Equivalent |
| K921883 | ENDOSCOPE | Nov 23, 1992 | Substantially Equivalent |