The following data is part of a premarket notification filed by Elscint, Inc. with the FDA for Extended Obstetrics Software Computation Package.
| Device ID | K890637 |
| 510k Number | K890637 |
| Device Name: | EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| Applicant | ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Contact | M Sobel,esq |
| Correspondent | M Sobel,esq ELSCINT, INC. 505 MAIN ST. SUITE 300 Hackensack, NJ 07601 |
| Product Code | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-08 |
| Decision Date | 1989-06-12 |