The following data is part of a premarket notification filed by Ge Healthcare Information Technologies, Inc. with the FDA for Mac-lab Recording Systems Altix, Cardiolab Recording Systems Altix, Combolab Recording Systems Altix, Mlcl Client Software Altix.
| Device ID | K213972 |
| 510k Number | K213972 |
| Device Name: | Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | GE Healthcare Information Technologies, Inc. 9900 Innovation Dr. Wauwatosa, WI 53226 |
| Contact | James T Turner |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-12-20 |
| Decision Date | 2022-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278516015 | K213972 | 000 |
| 00195278507525 | K213972 | 000 |
| 00195278507051 | K213972 | 000 |
| 00195278507044 | K213972 | 000 |