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)

HARMONIE SENSA

K-Number: K960273 · 1996-04-04

ApplicantStellate Systems
Decision Date1996-04-04
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HARMONIE SENSA is the device name listed in this FDA 510(k) record. The listed applicant is Stellate Systems. It received FDA 510(k) clearance on 1996-04-04 under 510(k) number K960273. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HARMONIE SENSA?

HARMONIE SENSA is a medical device that received FDA 510(k) clearance on 1996-04-04. The listed applicant is Stellate Systems. The 510(k) number is K960273.

When did HARMONIE SENSA receive FDA 510(k) clearance?

HARMONIE SENSA received FDA 510(k) clearance on 1996-04-04, under 510(k) number K960273.

Who is the listed applicant for HARMONIE SENSA?

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

What is the FDA product code for HARMONIE SENSA?

The FDA product code for HARMONIE SENSA is OMB.

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 Stellate Systems 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.

K083577HARMONIE SYSTEMK013450NOTTA AMBULATORY RECORDERK010728HARMONE-SCHWARZER EEG SYSTEMK982351LUNAK955577ECLIPSE VERSION 3.0K912938RHYTHM

View all 7 devices →

Related Devices (Code: OMB)

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.

K260998Ceribell Neurology Review SoftwareCeribell, Inc.K252070Ceribell Infant Seizure Detection SoftwareCeribell, Inc.K252160Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development, LLCK241589Ceribell Seizure Detection SoftwareCeribell, Inc.K243743autoSCORE (V 2.0.0)Holberg Eeg ASK242446Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15))Persyst Development Corporation

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.

↑