The following data is part of a premarket notification filed by Sonomed, Inc. with the FDA for Sonomed 4000p Ultrasonic Pachymeter.
| Device ID | K924311 |
| 510k Number | K924311 |
| Device Name: | SONOMED 4000P ULTRASONIC PACHYMETER |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SONOMED, INC. 3000 MARCUS AVE. Lake Success, NY 11042 |
| Contact | Louis Katz |
| Correspondent | Louis Katz SONOMED, INC. 3000 MARCUS AVE. Lake Success, NY 11042 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-26 |
| Decision Date | 1992-12-08 |