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FDA 510(k)

SPEMBLY 9000 & 9300

K-Number: K802063 · 1980-10-03

ApplicantSpembly Medical , Ltd.
Decision Date1980-10-03
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SPEMBLY 9000 & 9300 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 1980-10-03 under 510(k) number K802063. 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 SPEMBLY 9000 & 9300?

SPEMBLY 9000 & 9300 is a medical device that received FDA 510(k) clearance on 1980-10-03. The listed applicant is Spembly Medical , Ltd.. The 510(k) number is K802063.

When did SPEMBLY 9000 & 9300 receive FDA 510(k) clearance?

SPEMBLY 9000 & 9300 received FDA 510(k) clearance on 1980-10-03, under 510(k) number K802063.

Who is the listed applicant for SPEMBLY 9000 & 9300?

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 SPEMBLY 9000 & 9300?

The FDA product code for SPEMBLY 9000 & 9300 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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