FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
A O CUSTOM II CHAIR AND STAND
K Number: K801638
·
Decision Aug 13, 1980
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
15
Applicant Total
35
Review Days
27
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- A O CUSTOM II CHAIR AND STAND
- K Number
- K801638
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1140
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- American Optical Corp.
- Date Received
- July 17, 1980
- Decision Date
- August 13, 1980
- Product Code
- HME
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HME | Chair, Ophthalmic, Ac-Powered | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HME), ordered by most recent decision date.
MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR
FDA 510(k)
FDA Class 1
·Ophthalmic
BREATH-EASY, MODIFICATION
FDA 510(k)
FDA Class 1
·Ophthalmic
RELIANCE(R) 6200 EXAMINATION CHAIR
FDA 510(k)
FDA Class 1
·Ophthalmic
STORZ ENT/OPHTHALMIC MAXI CHAIR
FDA 510(k)
FDA Class 1
·Ophthalmic
MAC 150E OPTHALMIC CHAIR
FDA 510(k)
FDA Class 1
·Ophthalmic
MODEL 6500 OPTHALMIC CHAIR
FDA 510(k)
FDA Class 1
·Ophthalmic
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 |