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)

CIRCAMED HOLTER VERSION 4

K-Number: K894956 · 1990-02-05

ApplicantCircadian, Inc.
Decision Date1990-02-05
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CIRCAMED HOLTER VERSION 4 is the device name listed in this FDA 510(k) record. The listed applicant is Circadian, Inc.. It received FDA 510(k) clearance on 1990-02-05 under 510(k) number K894956. 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 CIRCAMED HOLTER VERSION 4?

CIRCAMED HOLTER VERSION 4 is a medical device that received FDA 510(k) clearance on 1990-02-05. The listed applicant is Circadian, Inc.. The 510(k) number is K894956.

When did CIRCAMED HOLTER VERSION 4 receive FDA 510(k) clearance?

CIRCAMED HOLTER VERSION 4 received FDA 510(k) clearance on 1990-02-05, under 510(k) number K894956.

Who is the listed applicant for CIRCAMED HOLTER VERSION 4?

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

What is the FDA product code for CIRCAMED HOLTER VERSION 4?

The FDA product code for CIRCAMED HOLTER VERSION 4 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 Circadian, 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.

K921878SCANMATE IIIK874641CIRCADIAN STRESS TEST IIK874155CIRCAMED MONITOR REMOTE START CONDUCTANCE METERK871251CIRCAMED FULL DISCLOSURE SYSTEMK860973CIRCADIAN STRESS TEST SYSTEMK851517CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITO

View all 13 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.

↑