The following data is part of a premarket notification filed by Sonomed, Inc. with the FDA for Pacscan Plus, Models 300p And 300ap.
Device ID | K092637 |
510k Number | K092637 |
Device Name: | PACSCAN PLUS, MODELS 300P AND 300AP |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | SONOMED, INC. 1979 MARCUS AVE. SUITE 105C Lake Success, NY 11040 |
Contact | Charles C O'neal |
Correspondent | Charles C O'neal SONOMED, INC. 1979 MARCUS AVE. SUITE 105C Lake Success, NY 11040 |
Product Code | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-08-27 |
Decision Date | 2009-09-24 |
Summary: | summary |