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FDA 510(k)

CONDUCTIVE GEL FOR ULTRASOUND

K-Number: K002832 · 2001-08-06

ApplicantSkylark Device & Systems Co., Ltd.
Decision Date2001-08-06
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CONDUCTIVE GEL FOR ULTRASOUND is the device name listed in this FDA 510(k) record. The listed applicant is Skylark Device & Systems Co., Ltd.. It received FDA 510(k) clearance on 2001-08-06 under 510(k) number K002832. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONDUCTIVE GEL FOR ULTRASOUND?

CONDUCTIVE GEL FOR ULTRASOUND is a medical device that received FDA 510(k) clearance on 2001-08-06. The listed applicant is Skylark Device & Systems Co., Ltd.. The 510(k) number is K002832.

When did CONDUCTIVE GEL FOR ULTRASOUND receive FDA 510(k) clearance?

CONDUCTIVE GEL FOR ULTRASOUND received FDA 510(k) clearance on 2001-08-06, under 510(k) number K002832.

Who is the listed applicant for CONDUCTIVE GEL FOR ULTRASOUND?

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

What is the FDA product code for CONDUCTIVE GEL FOR ULTRASOUND?

The FDA product code for CONDUCTIVE GEL FOR ULTRASOUND is GYB.

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Other records listing Skylark Device & Systems 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.

K053007SKYLARK URO PROBEK050174BIO-STIM KITK043306SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IRK034005SDS-4IK992652SD-730 IF-SDS, PERFECT PULSE IF-SDS

Related Devices (Code: GYB)

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.

K243749Jmoon Conductive GelShenzhen Ulike Smart Electronics Co., Ltd.K220735Avologi Gel Primer (Model: Av25)Premier North America, Inc.K222770Conductive GelTop-Rank Health Care Co., Ltd.K221724Conductive GelTone-A-Matic International, Inc.K212325EEG-acpSomnomedics GmbHK212326AC Cream - Conductive pasteSpes Medica Srl

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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