510(k) K203113
- Device
- Masimo SedLine Sedation Monitor And Accessories
- Applicant
- Masimo Corporation
- 510(k) number
- K203113
- Product code
- OLW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-02-25
- Date received
- 2020-10-15
- Regulation
- 882.1400
- Classification name
- Index-generating Electroencephalograph Software
- Medical specialty
- Neurology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sindura Penubarthi
- Address
- 52 Discovery Irvine CA US 92618 92618
FDA Registration Numbers#
- 3005783425
- 3009247326
- 3009077524
- 8044004
- 3016701404
- 3013500228
- 3010157426
- 3000126629
- 3012528160
- 3008657519
- 3008202779
- 9610816
- 3009831876
- 2221819
- 1651104
- 3032109181
- 3027256461
- 3008729547
- 3008716327
- 3016674095
- 3013679558
- 9610105
- 3007836437
- 3009156722
- 3013596024
- 3001570235
- 3004415095
- 3012359877
- 9710602
- 3019388613
- 3004203820
- 3008483389
- 3011353843
- 3007603826
- 3038281851
- 3005877899
- 8022257
- 3014461810
Source Documents#
Other 510(k) Records For Product Code OLW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230693 | BIS™ Advance Monitoring System | Covidien, LLC | 2024-02-26 |
| K213273 | Brain Anesthesia Response Monitor (Bar Monitor) | Cortical Dynamics , Ltd. | 2023-09-01 |
| K202621 | NeuroSENSE Monitoring System, Model NS-901 | Neurowave Systems, Inc. | 2021-08-05 |
| K172890 | SedLine Sedation Monitor | Masimo Corporation | 2018-01-26 |
| K150298 | Entropy Module, E-ENTROPY-01 | Ge Healthcare Filand OY | 2015-11-12 |
| K083063 | BIS INTERFACE FOR VITALOGIK PATIENT MONITORS | Mennen Medical , Ltd. | 2008-12-16 |
| K061907 | MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES | GE Healthcare | 2008-03-27 |
| K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX | Aspect Medical Systems, Inc. | 2007-11-20 |
| K071899 | BIS MODULE FOR ENVOY PATIENT MONITOR | Mennen Medical , Ltd. | 2007-10-22 |
| K062613 | BIS EEG MONITOR VIEW | Aspect Medical Systems, Inc. | 2007-06-18 |
| K060900 | SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 | Spacelabs Medical, Inc. | 2006-06-23 |
| K060997 | SNAP II EEG MONITOR | Everest Biomedical Instruments Co. | 2006-06-15 |
| K052981 | BIS EEG MONITOR, MODEL BISX4 | Aspect Medical Systems, Inc. | 2005-11-01 |
| K052362 | BIS EEG MONITOR, MODEL A-3000 | Aspect Medical Systems, Inc. | 2005-09-09 |
| K051874 | SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET | Physiometrix, Inc. | 2005-09-02 |
Legacy Summary#
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FDA Review#
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