The following data is part of a premarket notification filed by Echo Ultrasound with the FDA for Transesophageal Probe Holder & Disinfecting Column.
| Device ID | K903414 |
| 510k Number | K903414 |
| Device Name: | TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN |
| Classification | Echocardiograph |
| Applicant | ECHO ULTRASOUND R.D. 2, BOX 118 Reedsville, PA 17084 -9772 |
| Contact | David Szczupakowski |
| Correspondent | David Szczupakowski ECHO ULTRASOUND R.D. 2, BOX 118 Reedsville, PA 17084 -9772 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-30 |
| Decision Date | 1990-09-19 |