FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COOL-LITE FIBERCOPTIC LARYNGEAL EXAM
K Number: K830888
·
Decision Apr 27, 1983
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
21
Applicant Total
4
Review Days
37
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Basic Information
- Device Name
- COOL-LITE FIBERCOPTIC LARYNGEAL EXAM
- K Number
- K830888
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- National Medical Technology
- Date Received
- March 21, 1983
- Decision Date
- April 27, 1983
- 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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