FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECHOENCEPHALOGRAPH, DIGITAL, 1000
K Number: K770575
·
Decision Apr 26, 1977
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
6
Applicant Total
101
Review Days
29
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Basic Information
- Device Name
- ECHOENCEPHALOGRAPH, DIGITAL, 1000
- K Number
- K770575
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1240
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Storz Instrument Co.
- Date Received
- March 28, 1977
- Decision Date
- April 26, 1977
- Product Code
- GXW
- 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 |
|---|---|---|---|
| GXW | Echoencephalograph | FDA class 2 | Neurology |
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