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FDA 510(k)

OBSTETRIC PULSAR TWO CHANNEL TENS

K-Number: K840497 · 1984-04-16

ApplicantSpembly Medical , Ltd.
Decision Date1984-04-16
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OBSTETRIC PULSAR TWO CHANNEL TENS is the device name listed in this FDA 510(k) record. The listed applicant is Spembly Medical , Ltd.. It received FDA 510(k) clearance on 1984-04-16 under 510(k) number K840497. 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 OBSTETRIC PULSAR TWO CHANNEL TENS?

OBSTETRIC PULSAR TWO CHANNEL TENS is a medical device that received FDA 510(k) clearance on 1984-04-16. The listed applicant is Spembly Medical , Ltd.. The 510(k) number is K840497.

When did OBSTETRIC PULSAR TWO CHANNEL TENS receive FDA 510(k) clearance?

OBSTETRIC PULSAR TWO CHANNEL TENS received FDA 510(k) clearance on 1984-04-16, under 510(k) number K840497.

Who is the listed applicant for OBSTETRIC PULSAR TWO CHANNEL TENS?

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

What is the FDA product code for OBSTETRIC PULSAR TWO CHANNEL TENS?

The FDA product code for OBSTETRIC PULSAR TWO CHANNEL TENS is GZJ.

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Other records listing Spembly Medical , Ltd. 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.

K925129SELECTORK903303SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBESK901974SELECTOR ULTRASONIC SURGICAL ASPIRATORK882568130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAYK882963SPEMBLY MEDICAL 142 CRYO UNITK882962SERIES 40 & SERIES 42 CRYOPROBES (R SERIES)

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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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