FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL FBS-1, FLEXIBLE BRONCHOSCOPE
K Number: K811181
·
Decision May 13, 1981
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
238
Applicant Total
35
Review Days
15
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Basic Information
- Device Name
- MODEL FBS-1, FLEXIBLE BRONCHOSCOPE
- K Number
- K811181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- American Optical Corp.
- Date Received
- April 28, 1981
- Decision Date
- May 13, 1981
- Product Code
- EOQ
- 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 |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by American Optical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K950881 | PHACO TIP | Sep 6, 1995 | Substantially Equivalent |
| K950880 | AOI UNIVERSAL ULTRASONIC HANDPIECE | May 26, 1995 | Substantially Equivalent |
| K931358 | AORP4000 REUSABLE PAK | Feb 22, 1994 | Substantially Equivalent |
| K931354 | P4000 PHACOEMULSIFIER | Feb 22, 1994 | Substantially Equivalent |
| 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 |