FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Infinity M300
K Number: K200859
·
Decision Aug 28, 2020
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
411
Applicant Total
47
Review Days
149
Basic Information
- Device Name
- Infinity M300
- K Number
- K200859
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Draeger Medical Systems, Inc.
- Date Received
- April 1, 2020
- Decision Date
- August 28, 2020
- 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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