The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Dopplex-plb & Pxb.
| Device ID | K810115 |
| 510k Number | K810115 |
| Device Name: | DOPPLEX-PLB & PXB |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | HUNTLEIGH TECHNOLOGY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-16 |
| Decision Date | 1981-07-16 |