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Sd-602 Sd Mode 11, Sd-603 Sd Mod 111

by Skylark Device Co., Ltd.

510(k) K925729

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK925729 Date22 Jan 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GZJ
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a medical device identified as SD-602 SD MODE 11 and SD-603 SD MOD 111, manufactured by Skylark Device Co., Ltd. It was determined to be substantially equivalent to a predicate device under a traditional 510(k) clearance process. The device was reviewed by the Neurology advisory committee and received FDA clearance on January 22, 1993, under K925729 with product code GZJ.

The device was submitted for clearance on November 13, 1992, and is authorized for distribution in the United States. It is manufactured at the address: 12 Floor 34, Sec. 3 Chung Shan, N. Rd., Taipei, Taiwan, R.O.C. No further details regarding sterility, single-use or reusable status, MRI safety, sizes, storage, or clinical indications are provided in the data.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SD-602 SD MODE 11 and SD-603 SD MOD 111 device?

    The SD-602 SD MODE 11 and SD-603 SD MOD 111 are medical devices manufactured by Skylark Device Co., Ltd., identified by their specific model names and cleared under FDA 510(k) K925729 as substantially equivalent to a predicate device.

  • How was the SD-602 SD MODE 11 and SD-603 SD MOD 111 cleared for market?

    The device received FDA clearance through a traditional 510(k) submission process, where it was determined to be substantially equivalent to a legally marketed predicate device, based on review by the Neurology advisory committee.

  • When was the SD-602 SD MODE 11 and SD-603 SD MOD 111 cleared by the FDA?

    The device was cleared by the FDA on January 22, 1993, under 510(k) number K925729, following its submission on November 13, 1992, after evaluation by the Neurology advisory committee.