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FDA 510(k)

BOMED-EEA

K-Number: K853705 · 1986-01-13

ApplicantBomed Medical Mfr., Ltd.
Decision Date1986-01-13
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BOMED-EEA is the device name listed in this FDA 510(k) record. The listed applicant is Bomed Medical Mfr., Ltd.. It received FDA 510(k) clearance on 1986-01-13 under 510(k) number K853705. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOMED-EEA?

BOMED-EEA is a medical device that received FDA 510(k) clearance on 1986-01-13. The listed applicant is Bomed Medical Mfr., Ltd.. The 510(k) number is K853705.

When did BOMED-EEA receive FDA 510(k) clearance?

BOMED-EEA received FDA 510(k) clearance on 1986-01-13, under 510(k) number K853705.

Who is the listed applicant for BOMED-EEA?

The FDA 510(k) record lists Bomed Medical Mfr., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOMED-EEA?

The FDA product code for BOMED-EEA is DRX.

Related Clinical Trials

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Other records listing Bomed Medical Mfr., Ltd. 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.

K853706BOMED-CDMK831422BIOFLOWK831421BOMED BIOCONK830792PULSETTE 110 TRANSCUTANEOUS ELEC-NERVEK813020BOMED-NCCOMK811999BO MED BIA

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Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

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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