The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Hp Model M1318a Transvaginal Ultrasound Transducer.
| Device ID | K895026 |
| 510k Number | K895026 |
| Device Name: | HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER |
| Classification | Transducer, Ultrasonic, Obstetric |
| Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Contact | Charles R Burr |
| Correspondent | Charles R Burr HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Product Code | HGL |
| CFR Regulation Number | 884.2960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-08 |
| Decision Date | 1989-11-06 |