FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
K Number: K992636
·
Decision Aug 31, 1999
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
77
Applicant Total
230
Review Days
25
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Basic Information
- Device Name
- HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A
- K Number
- K992636
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hewlett-Packard Co.
- Date Received
- August 6, 1999
- Decision Date
- August 31, 1999
- Product Code
- DXJ
- 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 |
|---|---|---|---|
| DXJ | Display, Cathode-Ray Tube, Medical | FDA class 2 | Cardiovascular |
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Other Clearances by Hewlett-Packard Co.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K990339 | SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O | Feb 18, 1999 | Substantially Equivalent |