FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381
K Number: K822624
·
Decision Oct 6, 1982
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
74
Applicant Total
54
Review Days
37
Basic Information
- Device Name
- O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381
- K Number
- K822624
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- DEL MAR AVIONICS
- Date Received
- August 30, 1982
- Decision Date
- October 6, 1982
- Product Code
- IKN
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| IKN | Electromyograph, Diagnostic | FDA class 2 | Physical Medicine |
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