The following data is part of a premarket notification filed by Heartlung Corporation with the FDA for Abmd Software.
| Device ID | K213760 |
| 510k Number | K213760 |
| Device Name: | ABMD Software |
| Classification | Densitometer, Bone |
| Applicant | HeartLung Corporation 1124 W Carson St Torrance, CA 90502 |
| Contact | Morteza Naghavi |
| Correspondent | Lauren Lee HeartLung Corporation 1124 W Carson St Torrance, CA 90502 |
| Product Code | KGI |
| CFR Regulation Number | 892.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-01 |
| Decision Date | 2022-07-29 |