FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPMI CS
K Number: K883581
·
Decision Sep 13, 1988
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
17
Applicant Total
44
Review Days
22
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Basic Information
- Device Name
- OPMI CS
- K Number
- K883581
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4700
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Carl Zeiss, Inc.
- Date Received
- August 22, 1988
- Decision Date
- September 13, 1988
- Product Code
- EPT
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| EPT | Microscope, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EPT), ordered by most recent decision date.
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ZEISS VOICE CONTROL SYSTEM FOR OPMI'S
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|---|---|---|---|
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| K983868 | OPMI TWINER SURGICAL MICROSCOPE | Jan 29, 1999 | Substantially Equivalent |
| K965139 | SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM | Apr 23, 1997 | Substantially Equivalent |
| K961380 | CPC PROBE | Mar 17, 1997 | Substantially Equivalent |
| K961171 | HUMPHREY OCT SCANNER | Jun 21, 1996 | Substantially Equivalent |
| K954167 | HUMPHREY FIELD ANALYZER (HFA II) | Nov 24, 1995 | Substantially Equivalent |
| K952894 | VISULINK 900 ARGON | Aug 14, 1995 | Substantially Equivalent |
| K950985 | ZEISS ENDOLIVE STERO ENDOSCOPE | Mar 29, 1995 | Substantially Equivalent |