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FDA 510(k)

EMI THERAPY SIMULATOR

K-Number: K771817 · 1978-01-13

ApplicantEmi Therapy Systems, Inc.
Decision Date1978-01-13
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EMI THERAPY SIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Emi Therapy Systems, Inc.. It received FDA 510(k) clearance on 1978-01-13 under 510(k) number K771817. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMI THERAPY SIMULATOR?

EMI THERAPY SIMULATOR is a medical device that received FDA 510(k) clearance on 1978-01-13. The listed applicant is Emi Therapy Systems, Inc.. The 510(k) number is K771817.

When did EMI THERAPY SIMULATOR receive FDA 510(k) clearance?

EMI THERAPY SIMULATOR received FDA 510(k) clearance on 1978-01-13, under 510(k) number K771817.

Who is the listed applicant for EMI THERAPY SIMULATOR?

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

What is the FDA product code for EMI THERAPY SIMULATOR?

The FDA product code for EMI THERAPY SIMULATOR is JAD.

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 Emi Therapy Systems, 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.

K781084THERAPAX 150AK780948SYSTEM, PLANNING, TREATMENTK780027ACCELERATOR, LINEAR, MED.K771902EMI FOUR

Related Devices (Code: JAD)

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.

K250692GentleBeam (GB1000)Voxel Ray Solutions, LLCK241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, 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.

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