FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AO FLEXIBLE LARYNGOSCOPE, #LS-7
K Number: K802331
·
Decision Oct 10, 1980
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
7
Applicant Total
35
Review Days
17
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Basic Information
- Device Name
- AO FLEXIBLE LARYNGOSCOPE, #LS-7
- K Number
- K802331
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5530
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- American Optical Corp.
- Date Received
- September 23, 1980
- Decision Date
- October 10, 1980
- Product Code
- CAL
- 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 |
|---|---|---|---|
| CAL | Laryngoscope, Non-Rigid | FDA class 1 | Anesthesiology |
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| K931357 | AOD4000 DISPOSABLE PAK | Jan 25, 1994 | Substantially Equivalent |
| K820790 | FLEXIBLE PROCTOSIGMOIDOSCOPE, #FPS-3 | Apr 1, 1982 | Substantially Equivalent |
| K813430 | TISSUE PROCESSING CASSETTES & ACCESS | Dec 29, 1981 | Substantially Equivalent |
| K812965 | MODEL SC-6, FLEXIBLE SIAMOIDOSCOPE | Nov 2, 1981 | Substantially Equivalent |
| K812051 | PHOTOLITE AOLITE TINTOMATIC LENS | Sep 8, 1981 | Substantially Equivalent |
| K812063 | SR-1V DATA PRINTER | Aug 18, 1981 | Substantially Equivalent |