FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Dictum Health
K Number: K170798
·
Decision Jul 14, 2017
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
301
Applicant Total
1
Review Days
119
Basic Information
- Device Name
- Dictum Health
- K Number
- K170798
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dictum Health, Inc.
- Date Received
- March 17, 2017
- Decision Date
- July 14, 2017
- Product Code
- MWI
- 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 |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MWI), ordered by most recent decision date.
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
FDA 510(k)
FDA Class 2
·Cardiovascular
WARD-CSS (v1.2.x)
FDA 510(k)
FDA Class 2
·Cardiovascular
iCare APP
FDA 510(k)
FDA Class 2
·Cardiovascular
Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)
FDA 510(k)
FDA Class 2
·Cardiovascular
Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
FDA 510(k)
FDA Class 2
·Cardiovascular
AMC Health CareConsole
FDA 510(k)
FDA Class 2
·Cardiovascular