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FDA 510(k)

BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS

K-Number: K901548 · 1991-01-14

ApplicantShiley, Inc.
Decision Date1991-01-14
Product CodeCCC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1991-01-14 under 510(k) number K901548. The device is classified under product code CCC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS?

BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS is a medical device that received FDA 510(k) clearance on 1991-01-14. The listed applicant is Shiley, Inc.. The 510(k) number is K901548.

When did BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS receive FDA 510(k) clearance?

BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS received FDA 510(k) clearance on 1991-01-14, under 510(k) number K901548.

Who is the listed applicant for BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS?

The FDA 510(k) record lists Shiley, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS?

The FDA product code for BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS is CCC.

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Other records listing Shiley, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K920594SHILEY PERFUSION TUBING SETSK910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMK911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200K910923BCD ADVANCEDK903435SHILEY SPECIALIZED TRACHEOSTOMY TUBEK901624SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.

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Related Devices (Code: CCC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K071165ISCALERT SENSOR SYSTEMAlertis Medical ASK983198TRENDCARE CALIBRATOR MODEL SCU 7007Diametrics Medical, Ltd.K972314PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEMDiametrics Medical, Ltd.K953893PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEMBiomedical Sensors, Inc.K961790POINT-OF-CARE BLOOD GAS MONITOR SYSTEMOptical Sensors, Inc.K963935OLYMPUS CRITICAL CARE MONITORING SYSTEMOptical Sensors, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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