FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITAL SIGNS MONITOR-VSM 6000 SERIES
K Number: K101445
·
Decision Jun 8, 2010
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
305
Applicant Total
111
Review Days
15
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Basic Information
- Device Name
- VITAL SIGNS MONITOR-VSM 6000 SERIES
- K Number
- K101445
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Welch Allyn, Inc.
- Date Received
- May 24, 2010
- Decision Date
- June 8, 2010
- Product Code
- MWI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor | Jun 30, 2017 | Substantially Equivalent |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | Dec 19, 2014 | Substantially Equivalent |
| K132807 | MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) | Jan 31, 2014 | Substantially Equivalent |
| K132808 | VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR | Nov 20, 2013 | Substantially Equivalent |