The following data is part of a premarket notification filed by Echo Ultrasound with the FDA for Couplant Warming Device.
| Device ID | K893225 |
| 510k Number | K893225 |
| Device Name: | COUPLANT WARMING DEVICE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ECHO ULTRASOUND POST OFFICE BOX 552 Lewistown, PA 17044 |
| Contact | David Szczupakowski |
| Correspondent | David Szczupakowski ECHO ULTRASOUND POST OFFICE BOX 552 Lewistown, PA 17044 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-27 |
| Decision Date | 1989-10-12 |