FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
K Number: K030613
·
Decision Apr 17, 2003
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
22
Review Days
50
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Basic Information
- Device Name
- VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100
- K Number
- K030613
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Criticare Systems, Inc.
- Date Received
- February 26, 2003
- Decision Date
- April 17, 2003
- Product Code
- MHX
- 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 |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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Other Clearances by Criticare Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K101602 | VITAL SIGNS MONITOR | Sep 1, 2010 | Substantially Equivalent |
| K091050 | 506CN PATIENT MONITOR | May 27, 2009 | Substantially Equivalent |
| K042569 | 8600 VITAL SIGNS MONITOR | Sep 29, 2004 | Substantially Equivalent |
| K022435 | 507EL VITAL SIGNS MONITOR | Aug 14, 2002 | Substantially Equivalent |
| K012059 | 8100/8500 VITAL SIGNS MONITOR | Aug 1, 2001 | Substantially Equivalent |
| K001020 | 8100 VITAL SIGNS MONITOR | Apr 28, 2000 | Substantially Equivalent |
| K000276 | MPT 24 AND VITAL VIEW 24 | Mar 1, 2000 | Substantially Equivalent |
| K961223 | MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS | Dec 10, 1996 | Substantially Equivalent |
| K944860 | SCHOLAR PATIENT MONITOR | Jun 20, 1995 | Substantially Equivalent |
| K942737 | POET IQ WITH FIVE AGENT CAPABILITY | Feb 9, 1995 | Substantially Equivalent |