The following data is part of a premarket notification filed by Parexel Intl. Corp. with the FDA for L11, L12 Linear And C11, C12 Convex Array Transduc.
| Device ID | K904901 |
| 510k Number | K904901 |
| Device Name: | L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | PAREXEL INTL. CORP. ONE ALEWIFE PLACE Cambridge, MS 02140 |
| Contact | Barry Sall |
| Correspondent | Barry Sall PAREXEL INTL. CORP. ONE ALEWIFE PLACE Cambridge, MS 02140 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-30 |
| Decision Date | 1991-03-26 |