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FDA 510(k)

BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)

K-Number: K934051 · 1994-07-11

ApplicantSkylark Device Co., Ltd.
Decision Date1994-07-11
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD) is the device name listed in this FDA 510(k) record. The listed applicant is Skylark Device Co., Ltd.. It received FDA 510(k) clearance on 1994-07-11 under 510(k) number K934051. 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 BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)?

BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD) is a medical device that received FDA 510(k) clearance on 1994-07-11. The listed applicant is Skylark Device Co., Ltd.. The 510(k) number is K934051.

When did BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD) receive FDA 510(k) clearance?

BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD) received FDA 510(k) clearance on 1994-07-11, under 510(k) number K934051.

Who is the listed applicant for BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)?

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

What is the FDA product code for BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)?

The FDA product code for BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD) is GZJ.

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Other records listing Skylark Device Co., 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.

K990233ST-302 INFRAREXK984506SD-100 SKYEAR THERMOMETERK981449SD-956 ULTRASOUND THERAPYK983964BATCH #6060 CONDUCTIVE GELK964437GB-1002 TENS WITH MASSAGEK974585IF-727 INTERFERENTIAL STIMULATOR

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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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