FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SMR H-CHAIR
K Number: K800526
·
Decision Mar 18, 1980
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
31
Applicant Total
4
Review Days
11
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Basic Information
- Device Name
- SMR H-CHAIR
- K Number
- K800526
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.5300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Surgical Mechanical Research, Inc.
- Date Received
- March 7, 1980
- Decision Date
- March 18, 1980
- Product Code
- ETF
- 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 |
|---|---|---|---|
| ETF | Unit, Examining/Treatment, Ent | FDA class 1 | Ear, Nose, Throat |
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