The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Pediatric Energy Reducer, Models Aed-10 And Aed-20.
| Device ID | K040479 |
| 510k Number | K040479 |
| Device Name: | PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 |
| Classification | Automated External Defibrillators (non-wearable) |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | David Klementowski |
| Correspondent | David Klementowski WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | MKJ |
| CFR Regulation Number | 870.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-25 |
| Decision Date | 2004-09-14 |
| Summary: | summary |