The following data is part of a premarket notification filed by Applied Medical Research with the FDA for Acces. Analog Output Adaptor Model 910.
| Device ID | K780358 |
| 510k Number | K780358 |
| Device Name: | ACCES. ANALOG OUTPUT ADAPTOR MODEL 910 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | APPLIED MEDICAL RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-06 |
| Decision Date | 1978-04-28 |