FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED SITE FIBER OPTIC MODULE
K Number: K924198
·
Decision Nov 23, 1992
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
5
Applicant Total
34
Review Days
95
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Basic Information
- Device Name
- MODIFIED SITE FIBER OPTIC MODULE
- K Number
- K924198
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4335
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chiron Vision Corp.
- Date Received
- August 20, 1992
- Decision Date
- November 23, 1992
- Product Code
- FCT
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| FCT | Headlight, Fiberoptic Focusing | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FCT), ordered by most recent decision date.
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MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE
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FIBER OPTIC HEADLIGHT #60-0765
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FIBER OPTIC HEADLIGHT #60-0766766
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FIBER OPTIC ADJUSTABLE HEADLIGHT
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FDA Class 2
·Ophthalmic
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|---|---|---|---|
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| K960414 | SYNERGIST POWER PACK | Apr 24, 1996 | Substantially Equivalent |
| K944993 | IOLAB.SITE CD PHACOEMULSIFICATION MODULE | Oct 12, 1995 | Substantially Equivalent |
| K944995 | IOLAB/SITE PERISTALTIC MODULE | Oct 5, 1995 | Substantially Equivalent |
| K951292 | PASSPORT FOLDABLE LENS PLACEMENT SYSTEM | Jun 2, 1995 | Substantially Equivalent |
| K944994 | IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE | Mar 14, 1995 | Substantially Equivalent |
| K941550 | AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT | Nov 22, 1994 | Substantially Equivalent |
| K935233 | IOLAB LACRIMAL DUCT CATHETER | Sep 15, 1994 | Substantially Equivalent |
| K925606 | OPTICAL ZONE/HEXAGONAL/ASTIGMATISM/RADIAL MARKERS | Aug 29, 1994 | Substantially Equivalent |