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FDA 510(k)

IMEX RHYTHM TEK

K-Number: K890114 · 1989-07-27

ApplicantRacom, Inc.
Decision Date1989-07-27
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IMEX RHYTHM TEK is the device name listed in this FDA 510(k) record. The listed applicant is Racom, Inc.. It received FDA 510(k) clearance on 1989-07-27 under 510(k) number K890114. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMEX RHYTHM TEK?

IMEX RHYTHM TEK is a medical device that received FDA 510(k) clearance on 1989-07-27. The listed applicant is Racom, Inc.. The 510(k) number is K890114.

When did IMEX RHYTHM TEK receive FDA 510(k) clearance?

IMEX RHYTHM TEK received FDA 510(k) clearance on 1989-07-27, under 510(k) number K890114.

Who is the listed applicant for IMEX RHYTHM TEK?

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

What is the FDA product code for IMEX RHYTHM TEK?

The FDA product code for IMEX RHYTHM TEK is DSH.

Related Clinical Trials

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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Other records listing Racom, 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.

K900541LIFE-TEL CELLULAR TRANSCEIVER

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens 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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