FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cardiac Trigger Monitor
K Number: K170828
·
Decision May 17, 2017
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
334
Applicant Total
5
Review Days
58
Basic Information
- Device Name
- Cardiac Trigger Monitor
- K Number
- K170828
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ivy Biomedical Systems, Inc.
- Date Received
- March 20, 2017
- Decision Date
- May 17, 2017
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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