The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Huntleigh Dopcord, D140.
| Device ID | K854267 |
| 510k Number | K854267 |
| Device Name: | HUNTLEIGH DOPCORD, D140 |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
| Contact | James Britton |
| Correspondent | James Britton HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-23 |
| Decision Date | 1986-07-09 |