The following data is part of a premarket notification filed by Sonosite,inc. with the FDA for Sonoheart Hand-carried Echocardiography System.
| Device ID | K994096 |
| 510k Number | K994096 |
| Device Name: | SONOHEART HAND-CARRIED ECHOCARDIOGRAPHY SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SONOSITE,INC. 19807 NORTH CREEK PKWY., #200 Bothell, WA 98011 -8214 |
| Contact | Michael A Hoffman |
| Correspondent | Carole Stamp TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-12-03 |
| Decision Date | 1999-12-20 |
| Summary: | summary |