FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIRECT VIEW 2001 FIBERLIGHT
K Number: K945901
·
Decision Dec 27, 1994
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
63
Applicant Total
15
Review Days
25
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Basic Information
- Device Name
- DIRECT VIEW 2001 FIBERLIGHT
- K Number
- K945901
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5540
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mercury Medical
- Date Received
- December 2, 1994
- Decision Date
- December 27, 1994
- Product Code
- CCW
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CCW | Laryngoscope, Rigid | FDA class 1 | Anesthesiology |
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