FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR
K Number: K994331
·
Decision Jan 21, 2000
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
22
Applicant Total
475
Review Days
29
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Basic Information
- Device Name
- REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR
- K Number
- K994331
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Vascular
- Date Received
- December 23, 1999
- Decision Date
- January 21, 2000
- 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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