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 |