FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
K Number: K945826
·
Decision Aug 4, 1995
Classifications
1
FEI Numbers
113
Registration Numbers
113
Same Product Code
171
Applicant Total
30
Review Days
248
Basic Information
- Device Name
- J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS
- K Number
- K945826
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- MEDICAL DEVICE INSPECTION CO., INC.
- Date Received
- November 29, 1994
- Decision Date
- August 4, 1995
- Product Code
- HCC
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| HCC | Device, Biofeedback | FDA class 2 | Neurology |
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