FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLEXVIEW CLINICAL MONITORING SYSTEM
K Number: K003998
·
Decision Mar 7, 2001
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
116
Applicant Total
9
Review Days
71
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Basic Information
- Device Name
- FLEXVIEW CLINICAL MONITORING SYSTEM
- K Number
- K003998
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Data Critical Corp.
- Date Received
- December 26, 2000
- Decision Date
- March 7, 2001
- 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 Data Critical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K013156 | MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM | Oct 19, 2001 | Substantially Equivalent |
| K011999 | MODIFICATION TO FLEXVIEW CLINICAL MONITORING SYSTEM | Jul 24, 2001 | Substantially Equivalent |
| K012005 | MODIFICATION TO ALARMVIEW WIRELESS DATA NETWORK SYSTEM | Jul 24, 2001 | Substantially Equivalent |
| K010912 | ALARMVIEW WIRELESS DATA NETWORK SYSTEM | Apr 5, 2001 | Substantially Equivalent |
| K992848 | ALARMVIEW SYSTEM | Nov 19, 1999 | Substantially Equivalent |
| K990378 | STATVIEW SYSTEM | Sep 20, 1999 | Substantially Equivalent |
| K973527 | CARDIO-PAGER SYSTEM | Mar 31, 1998 | Substantially Equivalent |
| K971650 | RHYTHMSTAT XL | Dec 4, 1997 | Substantially Equivalent |