510(k) K994331
- Device
- REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR
- Applicant
- MEDTRONIC VASCULAR
- 510(k) number
- K994331
- Product code
- MXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-01-21
- Date received
- 1999-12-23
- Regulation
- 870.2800
- Classification name
- Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- NORA K HADDING
- Address
- 4000 Lexington Ave. N. Shoreview MN US 55126 55126
FDA Registration Numbers
- 3008494315
- 2182208
- 2017865
- 2134604
- 3012552532
- 3010659131
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Legacy Summary
summary
FDA Review
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