FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
K Number: K132039
·
Decision Feb 21, 2014
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
20
Applicant Total
92
Review Days
234
Basic Information
- Device Name
- ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
- K Number
- K132039
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- JEDMED INSTRUMENT CO.
- Date Received
- July 2, 2013
- Decision Date
- February 21, 2014
- Product Code
- EQN
- 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 |
|---|---|---|---|
| EQN | Laryngoscope, Nasopharyngoscope | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EQN), ordered by most recent decision date.
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Other Clearances by JEDMED INSTRUMENT CO.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K953457 | JEDMED SPECTRUM ENT CABINET | Aug 11, 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 |