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FDA 510(k)

GALVANIC UNIT

K-Number: K790949 · 1979-08-16

ApplicantRami International Corp.
Decision Date1979-08-16
Product CodeISB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

GALVANIC UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Rami International Corp.. It received FDA 510(k) clearance on 1979-08-16 under 510(k) number K790949. The device is classified under product code ISB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GALVANIC UNIT?

GALVANIC UNIT is a medical device that received FDA 510(k) clearance on 1979-08-16. The listed applicant is Rami International Corp.. The 510(k) number is K790949.

When did GALVANIC UNIT receive FDA 510(k) clearance?

GALVANIC UNIT received FDA 510(k) clearance on 1979-08-16, under 510(k) number K790949.

Who is the listed applicant for GALVANIC UNIT?

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

What is the FDA product code for GALVANIC UNIT?

The FDA product code for GALVANIC UNIT is ISB.

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

Related Devices (Code: ISB)

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.

K842805IMPULS 3, IT SELECTORRobert Bosch Corp.K842262PIRD-YPirdy, Inc.K780632MAXICEPTORMed GeneralK780730FIGURETRIMJay-Mar INternational Enterprises, IN

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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