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FDA 510(k)

STIMULATOR, BATTERY POWERED

K-Number: K790123 · 1979-02-06

ApplicantIntermedics, Inc.
Decision Date1979-02-06
Product CodeBXN
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STIMULATOR, BATTERY POWERED is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1979-02-06 under 510(k) number K790123. 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 STIMULATOR, BATTERY POWERED?

STIMULATOR, BATTERY POWERED is a medical device that received FDA 510(k) clearance on 1979-02-06. The listed applicant is Intermedics, Inc.. The 510(k) number is K790123.

When did STIMULATOR, BATTERY POWERED receive FDA 510(k) clearance?

STIMULATOR, BATTERY POWERED received FDA 510(k) clearance on 1979-02-06, under 510(k) number K790123.

Who is the listed applicant for STIMULATOR, BATTERY POWERED?

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

What is the FDA product code for STIMULATOR, BATTERY POWERED?

The FDA product code for STIMULATOR, BATTERY POWERED is BXN.

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Other records listing Intermedics, 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.

K954610MODEL 430-07 ENDOCARDIAL PACING LEADK955122INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADK962174BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)K955550CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEADK960281IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORYK954719INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD

View all 211 devices →

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

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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