Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (K242562)
Description
Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P by Ge Medical Systems Information Technologies, Inc., an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242562
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (K242562) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213363 | CARESCAPE B450, E-musb | GE Healthcare Finland Oy | 2022 |
| K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P,... | Ge Medical Systems Information Tech... | 2022 |
| K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX | Aspect Medical Systems, Inc. | 2007 |
| K052145 | DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES | GE Healthcare | 2005 |
Trace the full predicate network for K242562
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.