FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SOM 6V
K Number: K910357
·
Decision Feb 19, 1991
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
14
Applicant Total
92
Review Days
21
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Basic Information
- Device Name
- SOM 6V
- K Number
- K910357
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4700
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Jedmed Instrument Co.
- Date Received
- January 29, 1991
- Decision Date
- February 19, 1991
- Product Code
- FSO
- 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 |
|---|---|---|---|
| FSO | Microscope, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FSO), ordered by most recent decision date.
MICROFLEX
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SOM 6VI (SURGICAL OPERATING MICROSCOPE)
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WOODLYN OPERATION MICROSCOPE
FDA 510(k)
FDA Class 1
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MOLLER-WEDEL OPERATING MICROSCOPE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |