The following data is part of a premarket notification filed by Medical Cables, Inc. with the FDA for Transducers For Fetal Ultrasonic And Tokodynamometer Monitoring.
| Device ID | K010920 |
| 510k Number | K010920 |
| Device Name: | TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING |
| Classification | Monitor, Heart Rate, Fetal, Ultrasonic |
| Applicant | MEDICAL CABLES, INC. 1340 LOGAN AVE. Costa Mesa, CA 92626 |
| Contact | Robert Hilman |
| Correspondent | Robert Hilman MEDICAL CABLES, INC. 1340 LOGAN AVE. Costa Mesa, CA 92626 |
| Product Code | HEL |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-27 |
| Decision Date | 2001-06-22 |