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)

DUAL GRAPH (TM) RECORDER-MONITOR

K-Number: K890711 · 1989-06-02

ApplicantSomatics, Inc.
Decision Date1989-06-02
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DUAL GRAPH (TM) RECORDER-MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Somatics, Inc.. It received FDA 510(k) clearance on 1989-06-02 under 510(k) number K890711. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUAL GRAPH (TM) RECORDER-MONITOR?

DUAL GRAPH (TM) RECORDER-MONITOR is a medical device that received FDA 510(k) clearance on 1989-06-02. The listed applicant is Somatics, Inc.. The 510(k) number is K890711.

When did DUAL GRAPH (TM) RECORDER-MONITOR receive FDA 510(k) clearance?

DUAL GRAPH (TM) RECORDER-MONITOR received FDA 510(k) clearance on 1989-06-02, under 510(k) number K890711.

Who is the listed applicant for DUAL GRAPH (TM) RECORDER-MONITOR?

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

What is the FDA product code for DUAL GRAPH (TM) RECORDER-MONITOR?

The FDA product code for DUAL GRAPH (TM) RECORDER-MONITOR is DSF.

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 Somatics, 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.

K992269VENTIL-A ORAL PROTECTORK945120THYMATRON 2000 ELECTROCONVULSIVE SYSTEMK890710DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDSK882809THYMAPADK864181SOMATICS MOUTH GUARD (BITE BLOCK)K843923THYMATRON

View all 7 devices →

Related Devices (Code: DSF)

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.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel Medical, Inc.

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.

↑