The following data is part of a premarket notification filed by Allergan Humphrey with the FDA for Allergan Humphrey A/b Scan , Model 835.
| Device ID | K902582 |
| 510k Number | K902582 |
| Device Name: | ALLERGAN HUMPHREY A/B SCAN , MODEL 835 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ALLERGAN HUMPHREY 3081 TEAGARDEN ST. San Leandro, CA 94577 |
| Contact | Berry Dodd |
| Correspondent | Berry Dodd ALLERGAN HUMPHREY 3081 TEAGARDEN ST. San Leandro, CA 94577 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-12 |
| Decision Date | 1990-08-14 |