FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORL Video NasoPharyngo-Larngoscope
K Number: K150248
·
Decision Jul 23, 2015
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
20
Applicant Total
1
Review Days
170
Basic Information
- Device Name
- ORL Video NasoPharyngo-Larngoscope
- K Number
- K150248
- 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 COMPANY
- Date Received
- February 3, 2015
- Decision Date
- July 23, 2015
- 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 |
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