The following data is part of a premarket notification filed by American I.v. Products, Inc. with the FDA for Transducer For Ultrasound Fetal Monitoring, Models Fm10833 And Fm10834.
| Device ID | K040819 |
| 510k Number | K040819 |
| Device Name: | TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834 |
| Classification | System, Monitoring, Perinatal |
| Applicant | AMERICAN I.V. PRODUCTS, INC. 7485 SHIPLEY AVE. Hanover, MD 21076 |
| Contact | Gregory Falk |
| Correspondent | Gregory Falk AMERICAN I.V. PRODUCTS, INC. 7485 SHIPLEY AVE. Hanover, MD 21076 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-30 |
| Decision Date | 2004-08-16 |
| Summary: | summary |