The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Cozumel Diagnostic Ultrasound System.
| Device ID | K981505 |
| 510k Number | K981505 |
| Device Name: | COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | SONOSITE,INC. 22100 BOTHELL EVERETTE HWY. Bothell, WA 98041 -3003 |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1998-04-24 |
| Decision Date | 1998-05-08 |
| Summary: | summary |