FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
ENGUARD REMOTE PATIENT MONITOR
K Number: K020632
·
Decision Mar 15, 2002
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
20
Applicant Total
21
Review Days
16
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Basic Information
- Device Name
- ENGUARD REMOTE PATIENT MONITOR
- K Number
- K020632
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mennen Medical , Ltd.
- Date Received
- February 27, 2002
- Decision Date
- March 15, 2002
- Product Code
- QYX
- 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 |
|---|---|---|---|
| QYX | Outpatient Cardiac Telemetry | FDA class 2 | Cardiovascular |
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