Atlas FDA

OXYGEN ANALYZER 110

FDA 510(k) clearance K780185 · decided 1978-03-17

Clearance details

K-number
K780185
Device name
OXYGEN ANALYZER 110
Applicant
Siemens Corp.
Decision
Substantially Equivalent
Date received
1978-02-06
Decision date
1978-03-17
Days to decision
39 days
Clearance type
Traditional
Product code
CCC
Device class
2
Regulation number
868.1150
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Siemens Corp.

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.

RecordFirmDate
ISCALERT SENSOR SYSTEM (K071165)Alertis Medical AS2007-11-07
TRENDCARE CALIBRATOR MODEL SCU 7007 (K983198)Diametrics Medical, Ltd.1999-11-23
PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM (K972314)Diametrics Medical, Ltd.1997-12-19
PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM (K953893)Biomedical Sensors, Inc.1997-11-04
POINT-OF-CARE BLOOD GAS MONITOR SYSTEM (K961790)Optical Sensors, Inc.1997-04-09
OLYMPUS CRITICAL CARE MONITORING SYSTEM (K963935)Optical Sensors, Inc.1997-01-23
POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM (K951094)Optical Sensors, Inc.1996-01-16
PARATREND 7 SATELLITE INTRAVASCULAR BLOOD GAS MONITORING SYSTEM (K940188)Biomedical Sensors, Ltd.1995-11-13
SENSICATH POINT-OF-CARE BLOOD GAS MONITORING SYSTE (K931185)Optical Sensors, Inc.1993-10-21
BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS (K901548)Shiley, Inc.1991-01-14
MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING (K891013)Medtronic Vascular1989-08-02
INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY (K870911)American Bentley1987-05-29

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Atellica IM Hepatitis B surface Antigen II (HBsII) & Atellica IM Hepatitis B surface Antigen II Confirmatory (P110041/S017)Siemens Corp.2025-10-17
Atellica IM Hepatitis B surface Antigen II (HBsII) (P110041/S016)Siemens Corp.2025-10-17
ADVIA Centaur HBsAgII (HBsII) (P110041/S014)Siemens Corp.2025-06-04
ADVIA Centaur HBsAgII (HBsII) and ADVIA Centaur HBsAgII Confirmatory (HBsII Conf) Assay (P110041/S015)Siemens Corp.2025-03-04
Atellica® IM Hepatitis B surface Antigen II (HBsll), Atellica® IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Con (P110041/S013)Siemens Corp.2022-03-29
Atellica IM Hepatitis B surface Antigen II (HBsll), Atellica IM Hepatitis B surface Antigen 11 Confirmatory (HBsll Conf) (P110041/S012)Siemens Corp.2021-04-27
ADVIA Centaur HBsAg II(HBsII), ADVIA Centaur HBsAg Confirmatory, ADVIA Centaur HBsAg Quality Control Material, Atellica (P110041/S011)Siemens Corp.2021-03-11
ADVIA Centaur HBsAgII/Confirmatory Readypack Reagents and QC Material (P110041/S010)Siemens Corp.2020-08-25