FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM
K Number: K905728
·
Decision Mar 15, 1991
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
47
Applicant Total
230
Review Days
81
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Basic Information
- Device Name
- SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM
- K Number
- K905728
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2120
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Hewlett-Packard Co.
- Date Received
- December 24, 1990
- Decision Date
- March 15, 1991
- Product Code
- DPT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DPT | Probe, Blood-Flow, Extravascular | FDA class 2 | Cardiovascular |
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Other Clearances by Hewlett-Packard Co.
| K Number | Device Name | ||
|---|---|---|---|
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| K993516 | HP M2600A VIRIDIA TELEMETRY SYSTEM | Nov 8, 1999 | Substantially Equivalent |
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| K992636 | HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A | Aug 31, 1999 | Substantially Equivalent |
| K991871 | HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A | Aug 5, 1999 | Substantially Equivalent |
| K984194 | HP M2376A DEVICE LINK SYSTEM | Apr 30, 1999 | Substantially Equivalent |
| K990400 | LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM | Feb 24, 1999 | Substantially Equivalent |