ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING
FDA 510(k) clearance K081081 · decided 2009-03-09
Clearance details
- K-number
- K081081
- Device name
- ZOLL E SERIES WITH BLUETOOTH DIAL UP NETWORKING
- Applicant
- Zoll Medical Corporation, World Wide Headquarters
- Decision
- Substantially Equivalent
- Date received
- 2008-04-16
- Decision date
- 2009-03-09
- Days to decision
- 327 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Chelsmford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.