The following data is part of a premarket notification filed by Edwards Laboratories with the FDA for Ac Adapter:models 9525,9526,9527.
| Device ID | K781535 |
| 510k Number | K781535 |
| Device Name: | AC ADAPTER:MODELS 9525,9526,9527 |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | EDWARDS LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-06 |
| Decision Date | 1978-09-15 |