FDA 510(k)
FDA class 1
Substantially Equivalent
🇦🇺 Australia
BELSCOPE LARYNGOSCOPE
K Number: K904918
·
Decision Jul 22, 1991
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
63
Applicant Total
1
Review Days
264
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Basic Information
- Device Name
- BELSCOPE LARYNGOSCOPE
- K Number
- K904918
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5540
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Avulunga Pty. , Ltd.
- Date Received
- October 31, 1990
- Decision Date
- July 22, 1991
- 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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