The following data is part of a premarket notification filed by Epic Medical Equipment Services, Inc. with the FDA for Transducers For Ultrasound And Tocodynamometer Fetal Monitoring.
| Device ID | K992811 |
| 510k Number | K992811 |
| Device Name: | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | EPIC MEDICAL EQUIPMENT SERVICES, INC. 1800 10TH ST., SUITE 300 Plano, TX 75074 |
| Contact | Krista Oakes |
| Correspondent | Krista Oakes EPIC MEDICAL EQUIPMENT SERVICES, INC. 1800 10TH ST., SUITE 300 Plano, TX 75074 |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-20 |
| Decision Date | 2000-01-18 |
| Summary: | summary |