The following data is part of a premarket notification filed by Siemens Medical Laboratories, Inc. with the FDA for Sonoline Cf.
| Device ID | K875272 |
| 510k Number | K875272 |
| Device Name: | SONOLINE CF |
| Classification | Echocardiograph |
| Applicant | SIEMENS MEDICAL LABORATORIES, INC. ULTRASOUND DIVISION 5675 GIBRALTAR DRIVE Pleasanton, CA 94566 |
| Contact | K Johnson |
| Correspondent | K Johnson SIEMENS MEDICAL LABORATORIES, INC. ULTRASOUND DIVISION 5675 GIBRALTAR DRIVE Pleasanton, CA 94566 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-24 |
| Decision Date | 1988-02-18 |