Atlas FDA

BIS™ Advance Monitoring System

FDA 510(k) clearance K230693 · decided 2024-02-26

Clearance details

K-number
K230693
Device name
BIS™ Advance Monitoring System
Applicant
Covidien, LLC
Decision
Substantially Equivalent
Date received
2023-03-13
Decision date
2024-02-26
Days to decision
350 days
Clearance type
Traditional
Product code
OLW
Device class
2
Regulation number
882.1400
Medical specialty
Neurology
Advisory committee
Neurology
Location
Boulder, CO, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
SedLine Sedation Monitor (K260880)Masimo Corporation2026-07-10
Brain Anesthesia Response Monitor (Bar Monitor) (K213273)Cortical Dynamics , Ltd.2023-09-01
Masimo SedLine Sedation Monitor and Accessories (K203113)Masimo Corporation2022-02-25
NeuroSENSE Monitoring System, Model NS-901 (K202621)Neurowave Systems, Inc.2021-08-05
SedLine Sedation Monitor (K172890)Masimo Corporation2018-01-26
Entropy Module, E-ENTROPY-01 (K150298)Ge Healthcare Filand OY2015-11-12
BIS INTERFACE FOR VITALOGIK PATIENT MONITORS (K083063)Mennen Medical , Ltd.2008-12-16
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES (K061907)GE Healthcare2008-03-27
BIS EEG VISTA MONITOR SYSTEM AND BISX (K072286)Aspect Medical Systems, Inc.2007-11-20
BIS MODULE FOR ENVOY PATIENT MONITOR (K071899)Mennen Medical , Ltd.2007-10-22
BIS EEG MONITOR VIEW (K062613)Aspect Medical Systems, Inc.2007-06-18
SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 (K060900)Spacelabs Medical, Inc.2006-06-23

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S012)Covidien, LLC2005-06-24
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S011)Covidien, LLC2005-02-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S006)Covidien, LLC2003-01-07
OXI FIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S009)Covidien, LLC2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S008)Covidien, LLC2002-11-25
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S010)Covidien, LLC2002-11-15
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S005)Covidien, LLC2002-06-28
OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM (P990053/S007)Covidien, LLC2002-04-18