The following data is part of a premarket notification filed by Echo Ultrasound with the FDA for Phonocardiograph.
| Device ID | K924054 |
| 510k Number | K924054 |
| Device Name: | PHONOCARDIOGRAPH |
| Classification | Phonocardiograph |
| Applicant | ECHO ULTRASOUND R.D. 2, BOX 118 Reedsville, PA 17084 -9772 |
| Contact | Russell W Woods |
| Correspondent | Russell W Woods ECHO ULTRASOUND R.D. 2, BOX 118 Reedsville, PA 17084 -9772 |
| Product Code | DQC |
| CFR Regulation Number | 870.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-12 |
| Decision Date | 1993-01-22 |