ENVOY PATIENT MONITOR
FDA 510(k) clearance K024245 · decided 2004-05-10
Clearance details
- K-number
- K024245
- Device name
- ENVOY PATIENT MONITOR
- Applicant
- Mennen Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-23
- Decision date
- 2004-05-10
- Days to decision
- 504 days
- Clearance type
- Traditional
- Product code
- OMC
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Rohovot, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.