The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Or-340 Intraoperative Ultrasound System.
| Device ID | K900881 |
| 510k Number | K900881 |
| Device Name: | OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Codman & Shurtleff, Inc. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Contact | James R Veale |
| Correspondent | James R Veale Codman & Shurtleff, Inc. C/O MEDICAL DEVICE CONSULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-26 |
| Decision Date | 1990-09-25 |