FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS
K Number: K921863
·
Decision Sep 28, 1992
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
6
Applicant Total
230
Review Days
164
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Basic Information
- Device Name
- SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS
- K Number
- K921863
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1240
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hewlett-Packard Co.
- Date Received
- April 17, 1992
- Decision Date
- September 28, 1992
- Product Code
- GXW
- Advisory Committee
- Neurology
- Review Advisory Committee
- RA
- 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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