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FDA 510(k)

CALIBRATION GAS FOR SERVO GAS MONITOR 120

K-Number: K863675 · 1986-11-03

ApplicantSiemens Elema AB
Decision Date1986-11-03
Product CodeBXK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CALIBRATION GAS FOR SERVO GAS MONITOR 120 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Elema AB. It received FDA 510(k) clearance on 1986-11-03 under 510(k) number K863675. The device is classified under product code BXK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALIBRATION GAS FOR SERVO GAS MONITOR 120?

CALIBRATION GAS FOR SERVO GAS MONITOR 120 is a medical device that received FDA 510(k) clearance on 1986-11-03. The listed applicant is Siemens Elema AB. The 510(k) number is K863675.

When did CALIBRATION GAS FOR SERVO GAS MONITOR 120 receive FDA 510(k) clearance?

CALIBRATION GAS FOR SERVO GAS MONITOR 120 received FDA 510(k) clearance on 1986-11-03, under 510(k) number K863675.

Who is the listed applicant for CALIBRATION GAS FOR SERVO GAS MONITOR 120?

The FDA 510(k) record lists Siemens Elema AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALIBRATION GAS FOR SERVO GAS MONITOR 120?

The FDA product code for CALIBRATION GAS FOR SERVO GAS MONITOR 120 is BXK.

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Other records listing Siemens Elema AB 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.

K023354COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81EK010923KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392EK010925SERVOI VENTILATOR SYSTEM, MODEL 64 87 800 E407EK002137CATHCOR DESKTOPK001315MODIFICATION TO KION ANESTHESIA SYSTEMK970839SERVO VENTILATOR 300A

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Related Devices (Code: BXK)

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.

K954803BLOOD GAS MIXTURESMittler Supply, Inc.K954804LUNG DIFFUSION MIXTURESMittler Supply, Inc.K954542LUNG DIFFUSION MIXTURELiquid Technology Corp.K952838MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURESStandard Welders Supply Co.K953934MED-TECH LUNG DIFFUSION MIXTUREMedical Technical Gases Inc..K953208MEDICAL MIXTURE-CLINICAL BLOOD GAS MIXTURESStandard Welders Supply Co.

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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