The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for M1300a Ultrasound Imaging System, M1321a 3.5 Mhz.
| Device ID | K892355 |
| 510k Number | K892355 |
| Device Name: | M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany, DE |
| Contact | Ernst Schalk |
| Correspondent | Ernst Schalk HEWLETT-PACKARD CO. SCHUCKARDSTRABE 4 7030 BOBLINGEN Germany, DE |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-17 |
| Decision Date | 1989-07-24 |