FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11
K Number: K900607
·
Decision Oct 16, 1990
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
4
Review Days
250
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11
- K Number
- K900607
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cardiodata Corp.
- Date Received
- February 8, 1990
- Decision Date
- October 16, 1990
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSI), ordered by most recent decision date.
BodyGuardian Remote Monitoring System (BGRMS v3.0)
FDA 510(k)
FDA Class 2
·Cardiovascular
MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)
FDA 510(k)
FDA Class 2
·Cardiovascular
Zio AT® device (A100A1001)
FDA 510(k)
FDA Class 2
·Cardiovascular
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
FDA 510(k)
FDA Class 2
·Cardiovascular
SmartCardia 7L Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
Unified Arrhythmia Diagnostic System PocketECG IV
FDA 510(k)
FDA Class 2
·Cardiovascular