The following data is part of a premarket notification filed by Stethographics, Inc. with the FDA for Heart Stg System And Software.
| Device ID | K052283 |
| 510k Number | K052283 |
| Device Name: | HEART STG SYSTEM AND SOFTWARE |
| Classification | Stethoscope, Electronic |
| Applicant | STETHOGRAPHICS, INC. 1153 CENTRE STREET Boston, MA 02130 |
| Contact | Rozanne Paciej |
| Correspondent | Rozanne Paciej STETHOGRAPHICS, INC. 1153 CENTRE STREET Boston, MA 02130 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-22 |
| Decision Date | 2005-12-23 |
| Summary: | summary |