The following data is part of a premarket notification filed by Cardiostream, Llc with the FDA for Cardiostream Sonoaim.
| Device ID | K051853 |
| 510k Number | K051853 |
| Device Name: | CARDIOSTREAM SONOAIM |
| Classification | System, Image Processing, Radiological |
| Applicant | CARDIOSTREAM, LLC 2454 MCMULLEN BOOTH RD STE 427 Clearwater, FL 33759 |
| Contact | Ian P Gordon |
| Correspondent | Ian P Gordon CARDIOSTREAM, LLC 2454 MCMULLEN BOOTH RD STE 427 Clearwater, FL 33759 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-08 |
| Decision Date | 2005-08-22 |
| Summary: | summary |