FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
K Number: K081365
·
Decision Aug 15, 2008
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
22
Applicant Total
105
Review Days
92
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Basic Information
- Device Name
- SJM CONFIRM MODEL DM2100 IMPLANTABLE CARDIAC MONITOR AND MODEL DM2100A PATIENT ACTIVATOR
- K Number
- K081365
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- St Jude Medical
- Date Received
- May 15, 2008
- Decision Date
- August 15, 2008
- 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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