The following data is part of a premarket notification filed by Tenacore Holdings, Inc. with the FDA for Tenacore Transducers For Fetal Ultrasonic And Tokodynamometer Monitoring.
| Device ID | K043075 |
| 510k Number | K043075 |
| Device Name: | TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING |
| Classification | System, Monitoring, Perinatal |
| Applicant | TENACORE HOLDINGS, INC. 647 EAST YOUNG STREET Santa Ana, CA 92705 |
| Contact | Brand Caso |
| Correspondent | Brand Caso TENACORE HOLDINGS, INC. 647 EAST YOUNG STREET Santa Ana, CA 92705 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-08 |
| Decision Date | 2005-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852189007147 | K043075 | 000 |
| 10817522010830 | K043075 | 000 |
| 10817522010823 | K043075 | 000 |
| 10817522010816 | K043075 | 000 |
| 10817522010809 | K043075 | 000 |
| 10817522010793 | K043075 | 000 |
| 10817522010786 | K043075 | 000 |
| 10817522010779 | K043075 | 000 |
| 10817522010762 | K043075 | 000 |
| 10817522010755 | K043075 | 000 |
| 10817522010748 | K043075 | 000 |
| 10817522010731 | K043075 | 000 |
| 10817522010724 | K043075 | 000 |
| 10817522010717 | K043075 | 000 |
| 10817522010700 | K043075 | 000 |
| 10817522010694 | K043075 | 000 |
| 10817522010687 | K043075 | 000 |
| 10817522010670 | K043075 | 000 |
| 10817522010847 | K043075 | 000 |
| 10817522010854 | K043075 | 000 |
| 00852189007093 | K043075 | 000 |
| 00852189007086 | K043075 | 000 |
| 00852189007079 | K043075 | 000 |
| 00852189007055 | K043075 | 000 |
| 00852189007048 | K043075 | 000 |
| 00852189007031 | K043075 | 000 |
| 00852189007024 | K043075 | 000 |
| 00852189007017 | K043075 | 000 |
| 00852189007000 | K043075 | 000 |
| 10817522010939 | K043075 | 000 |
| 10817522010922 | K043075 | 000 |
| 10817522010915 | K043075 | 000 |
| 10817522010908 | K043075 | 000 |
| 10817522010892 | K043075 | 000 |
| 10817522010885 | K043075 | 000 |
| 10817522010878 | K043075 | 000 |
| 10817522010861 | K043075 | 000 |
| 10817522010663 | K043075 | 000 |