FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
K Number: K120774
·
Decision Apr 10, 2012
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
111
Review Days
27
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Basic Information
- Device Name
- ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
- K Number
- K120774
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Welch Allyn, Inc.
- Date Received
- March 14, 2012
- Decision Date
- April 10, 2012
- Product Code
- DSI
- 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
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