FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
eCareManager 4.1
K Number: K171322
·
Decision Aug 3, 2017
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
116
Applicant Total
7
Review Days
90
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Basic Information
- Device Name
- eCareManager 4.1
- K Number
- K171322
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Visicu, Inc.
- Date Received
- May 5, 2017
- Decision Date
- August 3, 2017
- Product Code
- MSX
- 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 |
|---|---|---|---|
| MSX | System, Network And Communication, Physiological Monitors | FDA class 2 | Cardiovascular |
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Other Clearances by Visicu, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K211046 | eCareManager 4.5 | Jun 3, 2022 | Substantially Equivalent |
| K171029 | eCareCoordinator | Jul 14, 2017 | Substantially Equivalent |
| K153156 | eCareManager 4.0.1 | Sep 30, 2016 | Substantially Equivalent |
| K141706 | ECARE COORDINATOR (ECC) | Sep 9, 2014 | Substantially Equivalent |
| K012171 | MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS | Jul 24, 2001 | Substantially Equivalent |
| K001972 | ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK | Oct 27, 2000 | Substantially Equivalent |