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FDA 510(k)

SHINMED MODEL SW-966 ULTRASONIC NEBULIZER

K-Number: K980024 · 1999-09-03

ApplicantShining World Health Care Co., Ltd.
Decision Date1999-09-03
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SHINMED MODEL SW-966 ULTRASONIC NEBULIZER is the device name listed in this FDA 510(k) record. The listed applicant is Shining World Health Care Co., Ltd.. It received FDA 510(k) clearance on 1999-09-03 under 510(k) number K980024. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHINMED MODEL SW-966 ULTRASONIC NEBULIZER?

SHINMED MODEL SW-966 ULTRASONIC NEBULIZER is a medical device that received FDA 510(k) clearance on 1999-09-03. The listed applicant is Shining World Health Care Co., Ltd.. The 510(k) number is K980024.

When did SHINMED MODEL SW-966 ULTRASONIC NEBULIZER receive FDA 510(k) clearance?

SHINMED MODEL SW-966 ULTRASONIC NEBULIZER received FDA 510(k) clearance on 1999-09-03, under 510(k) number K980024.

Who is the listed applicant for SHINMED MODEL SW-966 ULTRASONIC NEBULIZER?

The FDA 510(k) record lists Shining World Health Care Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHINMED MODEL SW-966 ULTRASONIC NEBULIZER?

The FDA product code for SHINMED MODEL SW-966 ULTRASONIC NEBULIZER is CAF.

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Other records listing Shining World Health Care 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.

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Related Devices (Code: CAF)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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