FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Confirm Rx Insertable Cardiac Monitor
K Number: K182981
·
Decision Mar 29, 2019
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
22
Applicant Total
12
Review Days
151
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Basic Information
- Device Name
- Confirm Rx Insertable Cardiac Monitor
- K Number
- K182981
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott
- Date Received
- October 29, 2018
- Decision Date
- March 29, 2019
- Product Code
- MXC
- 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 |
|---|---|---|---|
| MXC | Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) | FDA class 2 | Cardiovascular |
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