The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Acuson Heartsound/pulse/respiration Module.
| Device ID | K900560 |
| 510k Number | K900560 |
| Device Name: | ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE |
| Classification | Phonocardiograph |
| Applicant | ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
| Contact | T Johnson |
| Correspondent | T Johnson ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
| Product Code | DQC |
| CFR Regulation Number | 870.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-07 |
| Decision Date | 1990-12-03 |