Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MONITOR, ELECTROCARDIOSCOPE

K-Number: K760266 · 1976-10-13

ApplicantBurdick Corp.
Decision Date1976-10-13
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MONITOR, ELECTROCARDIOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Burdick Corp.. It received FDA 510(k) clearance on 1976-10-13 under 510(k) number K760266. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITOR, ELECTROCARDIOSCOPE?

MONITOR, ELECTROCARDIOSCOPE is a medical device that received FDA 510(k) clearance on 1976-10-13. The listed applicant is Burdick Corp.. The 510(k) number is K760266.

When did MONITOR, ELECTROCARDIOSCOPE receive FDA 510(k) clearance?

MONITOR, ELECTROCARDIOSCOPE received FDA 510(k) clearance on 1976-10-13, under 510(k) number K760266.

Who is the listed applicant for MONITOR, ELECTROCARDIOSCOPE?

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

What is the FDA product code for MONITOR, ELECTROCARDIOSCOPE?

The FDA product code for MONITOR, ELECTROCARDIOSCOPE is DPS.

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 Burdick Corp. 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.

K942565ALTAIR-DISC RECORDERK941351BURDICK PRO2 OXIMETERK903565E560 ELECTROCARDIOGRAPHK904032ELITE II ELECTROCARDIOGRAPHK900729NEOSERV 824K885085ERGOMED 840/ERGOMED 840L

View all 38 devices →

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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.

↑