ENGUARD REMOTE PATIENT MONITOR
FDA 510(k) clearance K020632 · decided 2002-03-15
Clearance details
- K-number
- K020632
- Device name
- ENGUARD REMOTE PATIENT MONITOR
- Applicant
- Mennen Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-27
- Decision date
- 2002-03-15
- Days to decision
- 16 days
- Clearance type
- Special
- Product code
- QYX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Rehovot, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.