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 |