PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
FDA 510(k) clearance K040479 · decided 2004-09-14
Clearance details
- K-number
- K040479
- Device name
- PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
- Applicant
- Welch Allyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-25
- Decision date
- 2004-09-14
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- MKJ
- Device class
- 3
- Regulation number
- 870.5310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Skaneateles Falls, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.