The following data is part of a premarket notification filed by Scientific Device Manufacturer Llc. with the FDA for Toco Transducer.
| Device ID | K952579 |
| 510k Number | K952579 |
| Device Name: | TOCO TRANSDUCER |
| Classification | Monitor, Uterine Contraction, External (for Use In Clinic) |
| Applicant | SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael, CA 94901 |
| Contact | Richard C Ball |
| Correspondent | Richard C Ball SCIENTIFIC DEVICE MANUFACTURER LLC. 999 ANDERSEN DRIVE, SUITE 120 San Rafael, CA 94901 |
| Product Code | HFM |
| CFR Regulation Number | 884.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-05 |
| Decision Date | 1995-08-04 |