FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
JEDMED SPECTRUM ENT CABINET
K Number: K953457
·
Decision Aug 11, 1995
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
31
Applicant Total
92
Review Days
21
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Basic Information
- Device Name
- JEDMED SPECTRUM ENT CABINET
- K Number
- K953457
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Jedmed Instrument Co.
- Date Received
- July 21, 1995
- Decision Date
- August 11, 1995
- Product Code
- ETF
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ETF | Unit, Examining/Treatment, Ent | FDA class 1 | Ear, Nose, Throat |
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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 |
| 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 |
| K941356 | MICROFLOW IRRIGATION SYSTEM | May 19, 1994 | Substantially Equivalent |