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)

CIRCADIAN STRESS TEST SYSTEM

K-Number: K860973 · 1986-08-25

ApplicantCircadian, Inc.
Decision Date1986-08-25
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CIRCADIAN STRESS TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Circadian, Inc.. It received FDA 510(k) clearance on 1986-08-25 under 510(k) number K860973. 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 CIRCADIAN STRESS TEST SYSTEM?

CIRCADIAN STRESS TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1986-08-25. The listed applicant is Circadian, Inc.. The 510(k) number is K860973.

When did CIRCADIAN STRESS TEST SYSTEM receive FDA 510(k) clearance?

CIRCADIAN STRESS TEST SYSTEM received FDA 510(k) clearance on 1986-08-25, under 510(k) number K860973.

Who is the listed applicant for CIRCADIAN STRESS TEST SYSTEM?

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 CIRCADIAN STRESS TEST SYSTEM?

The FDA product code for CIRCADIAN STRESS TEST SYSTEM 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 IIIK894956CIRCAMED HOLTER VERSION 4K874641CIRCADIAN STRESS TEST IIK874155CIRCAMED MONITOR REMOTE START CONDUCTANCE METERK871251CIRCAMED FULL DISCLOSURE 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.

↑