FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ATLAS MONITOR, MODELS 200,210,220
K Number: K022084
·
Decision Sep 26, 2002
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
111
Review Days
91
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Basic Information
- Device Name
- ATLAS MONITOR, MODELS 200,210,220
- K Number
- K022084
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Welch Allyn, Inc.
- Date Received
- June 27, 2002
- Decision Date
- September 26, 2002
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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| K223381 | iExaminer System with Panoptic Plus | Mar 15, 2023 | Substantially Equivalent |
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| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System | Jul 16, 2018 | Substantially Equivalent |
| 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 |