The following data is part of a premarket notification filed by Hewlett-packard Co. with the FDA for Linear Array Transducer,model Hp 21376, M2410a Ultrasound Imaging System.
| Device ID | K990400 |
| 510k Number | K990400 |
| Device Name: | LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | HEWLETT-PACKARD CO. 3000 MINUTEMAN RD. Andover, MA 01810 -1085 |
| Contact | Stephen B Singlar |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-02-09 |
| Decision Date | 1999-02-24 |
| Summary: | summary |