ONESTEP CPR II MULTI-FUNCTION ELECTRODE
FDA 510(k) clearance K133441 · decided 2014-10-10
Clearance details
- K-number
- K133441
- Device name
- ONESTEP CPR II MULTI-FUNCTION ELECTRODE
- Applicant
- Bio-Detek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-12
- Decision date
- 2014-10-10
- Days to decision
- 332 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.