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FDA 510(k)

ELECTRO-NERVE STIMULATOR B5/SK700B

K-Number: K844076 · 1985-01-23

ApplicantBiomedical Life Systems, Inc.
Decision Date1985-01-23
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTRO-NERVE STIMULATOR B5/SK700B is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Life Systems, Inc.. It received FDA 510(k) clearance on 1985-01-23 under 510(k) number K844076. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTRO-NERVE STIMULATOR B5/SK700B?

ELECTRO-NERVE STIMULATOR B5/SK700B is a medical device that received FDA 510(k) clearance on 1985-01-23. The listed applicant is Biomedical Life Systems, Inc.. The 510(k) number is K844076.

When did ELECTRO-NERVE STIMULATOR B5/SK700B receive FDA 510(k) clearance?

ELECTRO-NERVE STIMULATOR B5/SK700B received FDA 510(k) clearance on 1985-01-23, under 510(k) number K844076.

Who is the listed applicant for ELECTRO-NERVE STIMULATOR B5/SK700B?

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

What is the FDA product code for ELECTRO-NERVE STIMULATOR B5/SK700B?

The FDA product code for ELECTRO-NERVE STIMULATOR B5/SK700B is GZJ.

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Other records listing Biomedical Life 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.

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Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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