The following data is part of a premarket notification filed by Diagnostic Ultrasound Corp. with the FDA for Diagnostic Ultrasound 105 & 110.
| Device ID | K842539 |
| 510k Number | K842539 |
| Device Name: | DIAGNOSTIC ULTRASOUND 105 & 110 |
| Classification | Transducer, Ultrasonic |
| Applicant | DIAGNOSTIC ULTRASOUND CORP. P.O. BOX 0789 Kirkland, WA 98083 -0789 |
| Contact | Gerald Mcmorrow |
| Correspondent | Gerald Mcmorrow DIAGNOSTIC ULTRASOUND CORP. P.O. BOX 0789 Kirkland, WA 98083 -0789 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-28 |
| Decision Date | 1985-04-10 |