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FDA 510(k)

DIGISTIM II

K-Number: K822137 · 1982-07-30

ApplicantBeuro Technology
Decision Date1982-07-30
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DIGISTIM II is the device name listed in this FDA 510(k) record. The listed applicant is Beuro Technology. It received FDA 510(k) clearance on 1982-07-30 under 510(k) number K822137. The device is classified under product code BXN. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGISTIM II?

DIGISTIM II is a medical device that received FDA 510(k) clearance on 1982-07-30. The listed applicant is Beuro Technology. The 510(k) number is K822137.

When did DIGISTIM II receive FDA 510(k) clearance?

DIGISTIM II received FDA 510(k) clearance on 1982-07-30, under 510(k) number K822137.

Who is the listed applicant for DIGISTIM II?

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

What is the FDA product code for DIGISTIM II?

The FDA product code for DIGISTIM II is BXN.

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Related Devices (Code: BXN)

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.

K213049STIMPOD NMS450 Nerve StimulatorXavant Technology (Pty), Ltd.K162086MultiStim ECOPAJUNK GmbH MedizintechnologieK153045SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve StimulatorEasy Med Instrument Co., Ltd.K121743EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTINSunmed, LLCK111985MYOGUIDE SYSTEM MODEL 8008Intronix Technologies Corp.K110118STIMTRODE SINGLE USE NERVE STIMULATORXavant Technology (Pty), Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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