The following data is part of a premarket notification filed by Heartlab, Inc. with the FDA for Agfa Heartlab Cardiovascular.
| Device ID | K050228 |
| 510k Number | K050228 |
| Device Name: | AGFA HEARTLAB CARDIOVASCULAR |
| Classification | System, Image Processing, Radiological |
| Applicant | HEARTLAB, INC. 1 CROSSWIND RD. Westerly, RI 02891 |
| Contact | Richard Petrocelli |
| Correspondent | Richard Petrocelli HEARTLAB, INC. 1 CROSSWIND RD. Westerly, RI 02891 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-01 |
| Decision Date | 2005-02-18 |
| Summary: | summary |