FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
MODIFICATION TO ENVOY PATIENT MONITOR
K Number: K000563
·
Decision May 17, 2000
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
21
Review Days
85
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Basic Information
- Device Name
- MODIFICATION TO ENVOY PATIENT MONITOR
- K Number
- K000563
- 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 22, 2000
- Decision Date
- May 17, 2000
- Product Code
- MHX
- 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 |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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