Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
FDA 510(k) clearance K213490 · decided 2022-04-01
Clearance details
- K-number
- K213490
- Device name
- Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
- Applicant
- Ge Medical Systems Information Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-11-01
- Decision date
- 2022-04-01
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- MHX
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Wauwatosa, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ge Medical Systems Information Technologies
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 616 recall (Z-0455-2026) | GE Healthcare Finland Oy | 2025-11-07 |
| B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX, recall (Z-0729-2023) | GE Medical Systems, LLC | 2022-12-19 |
| B125P Patient Monitor (with E-module slot option), REF 6160000-002 recall (Z-0730-2023) | GE Medical Systems, LLC | 2022-12-19 |
| B105M Patient Monitor, REF 6160000-003 recall (Z-0731-2023) | GE Medical Systems, LLC | 2022-12-19 |
| B125M Patient Monitor, REF 6160000-004-XXXXXX recall (Z-0732-2023) | GE Medical Systems, LLC | 2022-12-19 |
| B125M Patient Monitor, REF 6160000-005-XXXXXXX recall (Z-0733-2023) | GE Medical Systems, LLC | 2022-12-19 |