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FDA 510(k)

DEMODULATOR/CARDIOTACHOMETER

K-Number: K761076 · 1976-12-28

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

Device Summary

DEMODULATOR/CARDIOTACHOMETER 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 K761076. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEMODULATOR/CARDIOTACHOMETER?

DEMODULATOR/CARDIOTACHOMETER is a medical device that received FDA 510(k) clearance on 1976-12-28. The listed applicant is Eldeco. The 510(k) number is K761076.

When did DEMODULATOR/CARDIOTACHOMETER receive FDA 510(k) clearance?

DEMODULATOR/CARDIOTACHOMETER received FDA 510(k) clearance on 1976-12-28, under 510(k) number K761076.

Who is the listed applicant for DEMODULATOR/CARDIOTACHOMETER?

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 DEMODULATOR/CARDIOTACHOMETER?

The FDA product code for DEMODULATOR/CARDIOTACHOMETER is DRT.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K761075SPORTS RECORDER (SR-10)K761073POCKET TRANSMITTER (PT-10)K761074DYNAMIC RECORDER (DR-10)K761077TREND ANALYZER

Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, 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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