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FDA 510(k)

DOBE (MODIFIED)

K-Number: K853993 · 1986-02-28

ApplicantPhoenix Medical Technology, Inc.
Decision Date1986-02-28
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DOBE (MODIFIED) is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Medical Technology, Inc.. It received FDA 510(k) clearance on 1986-02-28 under 510(k) number K853993. 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 DOBE (MODIFIED)?

DOBE (MODIFIED) is a medical device that received FDA 510(k) clearance on 1986-02-28. The listed applicant is Phoenix Medical Technology, Inc.. The 510(k) number is K853993.

When did DOBE (MODIFIED) receive FDA 510(k) clearance?

DOBE (MODIFIED) received FDA 510(k) clearance on 1986-02-28, under 510(k) number K853993.

Who is the listed applicant for DOBE (MODIFIED)?

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

What is the FDA product code for DOBE (MODIFIED)?

The FDA product code for DOBE (MODIFIED) is DRX.

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Other records listing Phoenix Medical Technology, 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.

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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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