The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Advance Disposable Pressure Transducer.
| Device ID | K904601 |
| 510k Number | K904601 |
| Device Name: | ADVANCE DISPOSABLE PRESSURE TRANSDUCER |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Contact | D Arkin |
| Correspondent | D Arkin ADVANCE MEDICAL DESIGNS, INC. 808 PICKENS INDUSTRIAL DR. Marietta, GA 30062 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-10 |
| Decision Date | 1990-12-17 |