The following data is part of a premarket notification filed by Pulsonic Ag, Medical Technology with the FDA for Cardioscope Sonoplus 3000.
| Device ID | K051126 |
| 510k Number | K051126 |
| Device Name: | CARDIOSCOPE SONOPLUS 3000 |
| Classification | Electrocardiograph |
| Applicant | PULSONIC AG, MEDICAL TECHNOLOGY 1308 MORNINGSIDE PARK DRIVE Alpharetta, GA 30022 |
| Contact | Jay Mansour |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-05-03 |
| Decision Date | 2005-05-19 |
| Summary: | summary |