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FDA 510(k)

DYNAMIC RECORDER (DR-10)

K-Number: K761074 · 1976-12-28

ApplicantEldeco
Decision Date1976-12-28
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DYNAMIC RECORDER (DR-10) is the device name listed in this FDA 510(k) record. The listed applicant is Eldeco. It received FDA 510(k) clearance on 1976-12-28 under 510(k) number K761074. 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 DYNAMIC RECORDER (DR-10)?

DYNAMIC RECORDER (DR-10) is a medical device that received FDA 510(k) clearance on 1976-12-28. The listed applicant is Eldeco. The 510(k) number is K761074.

When did DYNAMIC RECORDER (DR-10) receive FDA 510(k) clearance?

DYNAMIC RECORDER (DR-10) received FDA 510(k) clearance on 1976-12-28, under 510(k) number K761074.

Who is the listed applicant for DYNAMIC RECORDER (DR-10)?

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

What is the FDA product code for DYNAMIC RECORDER (DR-10)?

The FDA product code for DYNAMIC RECORDER (DR-10) 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 Eldeco 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.

K761076DEMODULATOR/CARDIOTACHOMETERK761075SPORTS RECORDER (SR-10)K761073POCKET TRANSMITTER (PT-10)K761077TREND ANALYZER

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

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

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