FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22
K Number: K993907
·
Decision Dec 6, 1999
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
30
Review Days
19
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Basic Information
- Device Name
- VIRIDIA INFORMATION CENTER SOFTWARE FOR M3154A OPT C22
- K Number
- K993907
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Agilent Technologies, Inc.
- Date Received
- November 17, 1999
- Decision Date
- December 6, 1999
- Product Code
- MHD
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| MHD | Pump, Infusion, Gallstone Dissolution | FDA class 2 | General Hospital |
Other Clearances by Agilent Technologies, Inc.
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|---|---|---|---|
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| K011824 | AGILENT M2636B TELEMON B MONITOR (TELEMON B) | Jul 2, 2001 | Substantially Equivalent |
| K010634 | HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B | Jun 11, 2001 | Substantially Equivalent |
| K011578 | M2376A DEVICELINK SYSTEM, MODEL M2376A | Jun 8, 2001 | Substantially Equivalent |
| K003819 | HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A | May 2, 2001 | Substantially Equivalent |
| K011093 | AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154 | May 1, 2001 | Substantially Equivalent |
| K010453 | M2376A DEVICELINK SYSTEM | Mar 2, 2001 | Substantially Equivalent |
| K010342 | M2376A DEVICELINK SYSTEM, MODEL M2376A | Feb 14, 2001 | Substantially Equivalent |
| K010048 | M2376A DEVICELINK SYSTEM | Feb 1, 2001 | Substantially Equivalent |