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FDA 510(k)

BESMED VARIOUS MODELS OF TENS, BE-550/BE-660

K-Number: K031374 · 2003-11-28

ApplicantBesmed Health Business Corp
Decision Date2003-11-28
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 is the device name listed in this FDA 510(k) record. The listed applicant is Besmed Health Business Corp. It received FDA 510(k) clearance on 2003-11-28 under 510(k) number K031374. 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 BESMED VARIOUS MODELS OF TENS, BE-550/BE-660?

BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 is a medical device that received FDA 510(k) clearance on 2003-11-28. The listed applicant is Besmed Health Business Corp. The 510(k) number is K031374.

When did BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 receive FDA 510(k) clearance?

BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 received FDA 510(k) clearance on 2003-11-28, under 510(k) number K031374.

Who is the listed applicant for BESMED VARIOUS MODELS OF TENS, BE-550/BE-660?

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

What is the FDA product code for BESMED VARIOUS MODELS OF TENS, BE-550/BE-660?

The FDA product code for BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 is GZJ.

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Other records listing Besmed Health Business Corp 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.

K241339Besmed Bacterial Filter and HMEFK172804Besmed Peak Flow MeterK160112Besmed PEEP ValveK091272BESMED JET NEBULIZER BOTTLE SETK031375BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580

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

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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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