FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAXI-CHAIR
K Number: K781801
·
Decision Nov 3, 1978
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
15
Applicant Total
4
Review Days
11
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Basic Information
- Device Name
- MAXI-CHAIR
- K Number
- K781801
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1140
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Surgical Mechanical Research, Inc.
- Date Received
- October 23, 1978
- Decision Date
- November 3, 1978
- 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 |
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