The following data is part of a premarket notification filed by Aloka Co., Ltd. with the FDA for Convex And Linear Array Transducers.
| Device ID | K923269 |
| 510k Number | K923269 |
| Device Name: | CONVEX AND LINEAR ARRAY TRANSDUCERS |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Contact | Carol Bennett |
| Correspondent | Carol Bennett ALOKA CO., LTD. 10 FAIRFIELD BLVD. Wallingford, CT 06492 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-06 |
| Decision Date | 1992-12-03 |