FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPERAID NUCLEUS
K Number: K841807
·
Decision Nov 21, 1984
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
39
Applicant Total
92
Review Days
204
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Basic Information
- Device Name
- OPERAID NUCLEUS
- K Number
- K841807
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4360
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Jedmed Instrument Co.
- Date Received
- May 1, 1984
- Decision Date
- November 21, 1984
- Product Code
- KYG
- 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 |
|---|---|---|---|
| KYG | Device, Irrigation, Ocular Surgery | FDA class 1 | Ophthalmic |
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Other Clearances by Jedmed Instrument Co.
| K Number | Device Name | ||
|---|---|---|---|
| K132039 | ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM | Feb 21, 2014 | Substantially Equivalent |
| K021750 | LID CHAIN EYELID WEIGHTS | Jan 27, 2003 | Substantially Equivalent |
| K954184 | JED-LIGHT FIBEROPTIC LIGHT SOURCE | Nov 13, 1995 | Substantially Equivalent |
| K944032 | VIDEO SCOPE SYSTEM (LARYNGOSCOPE) | Sep 15, 1995 | Substantially Equivalent |
| K950925 | JEDMED LARYNGEAL SCOPE | Aug 11, 1995 | Substantially Equivalent |
| K953457 | JEDMED SPECTRUM ENT CABINET | Aug 11, 1995 | Substantially Equivalent |
| K950785 | HORTMANN AIRMATIC AIR CALORIC STIMULATOR | Jun 28, 1995 | Substantially Equivalent |
| K950078 | MICROFLOW IRRIGATION SYSTEM | Jun 21, 1995 | Substantially Equivalent |
| K944671 | VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) | Feb 7, 1995 | Substantially Equivalent |
| K944031 | VIDEO SCOPE SYSTEM (OTOSCOPE) | Sep 23, 1994 | Substantially Equivalent |