FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RHINO-LARYNX STROBOSCOPE TYPE 4914
K Number: K842090
·
Decision Jul 18, 1984
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
7
Applicant Total
4
Review Days
55
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Basic Information
- Device Name
- RHINO-LARYNX STROBOSCOPE TYPE 4914
- K Number
- K842090
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4750
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Bruel & Kjaer Industri A/S
- Date Received
- May 24, 1984
- Decision Date
- July 18, 1984
- Product Code
- EQL
- 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 |
|---|---|---|---|
| EQL | Laryngostroboscope | FDA class 1 | Ear, Nose, Throat |
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