FDA 510(k)

IC-WHCD100 (Inspire)

K-Number: K183471 · 2020-07-02

Decision Date2020-07-02

Product CodeNBL

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

IC-WHCD100 (Inspire) is the device name listed in this FDA 510(k) record. The listed applicant is Good Doctors Co., Ltd.. It received FDA 510(k) clearance on 2020-07-02 under 510(k) number K183471. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IC-WHCD100 (Inspire)?

IC-WHCD100 (Inspire) is a medical device that received FDA 510(k) clearance on 2020-07-02. The listed applicant is Good Doctors Co., Ltd.. The 510(k) number is K183471.

When did IC-WHCD100 (Inspire) receive FDA 510(k) clearance?

IC-WHCD100 (Inspire) received FDA 510(k) clearance on 2020-07-02, under 510(k) number K183471.

Who is the listed applicant for IC-WHCD100 (Inspire)?

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

What is the FDA product code for IC-WHCD100 (Inspire)?

The FDA product code for IC-WHCD100 (Inspire) is NBL.

Other records listing Good Doctors 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.

K223507CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)K173157Dr's Light2 K171867Dr’s Finder NEO K151274Dr's Finder

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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.