EVERON
FDA 510(k) clearance K082465 · decided 2009-03-25
Clearance details
- K-number
- K082465
- Device name
- EVERON
- Applicant
- Earlysense, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-27
- Decision date
- 2009-03-25
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- BZQ
- Device class
- 2
- Regulation number
- 868.2375
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Ramat-Gan, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.