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)

EMISONIC 4500 TM

K-Number: K771930 · 1977-10-27

ApplicantEmi Medical, Inc.
Decision Date1977-10-27
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EMISONIC 4500 TM is the device name listed in this FDA 510(k) record. The listed applicant is Emi Medical, Inc.. It received FDA 510(k) clearance on 1977-10-27 under 510(k) number K771930. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMISONIC 4500 TM?

EMISONIC 4500 TM is a medical device that received FDA 510(k) clearance on 1977-10-27. The listed applicant is Emi Medical, Inc.. The 510(k) number is K771930.

When did EMISONIC 4500 TM receive FDA 510(k) clearance?

EMISONIC 4500 TM received FDA 510(k) clearance on 1977-10-27, under 510(k) number K771930.

Who is the listed applicant for EMISONIC 4500 TM?

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

What is the FDA product code for EMISONIC 4500 TM?

The FDA product code for EMISONIC 4500 TM is IYO.

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 Medical, 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.

K791429EMISONIC 4290K781936SCANNER-EMI 7020 AND 7020RK781519EMI SIMULATOR REMOTE CONTROL CONSOLEK781051EMISONIC 4201K780995COMPUTERIZED AXIAL TOMOGRAPHYK7809305543 INDEPENDENT VIEWING SYSTEM

View all 13 devices →

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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.

↑