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FDA 510(k)

CARE PAL, MODEL CPW-10X

K-Number: K091430 · 2009-08-21

ApplicantDigio2 International Co., Ltd.
Decision Date2009-08-21
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARE PAL, MODEL CPW-10X is the device name listed in this FDA 510(k) record. The listed applicant is Digio2 International Co., Ltd.. It received FDA 510(k) clearance on 2009-08-21 under 510(k) number K091430. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARE PAL, MODEL CPW-10X?

CARE PAL, MODEL CPW-10X is a medical device that received FDA 510(k) clearance on 2009-08-21. The listed applicant is Digio2 International Co., Ltd.. The 510(k) number is K091430.

When did CARE PAL, MODEL CPW-10X receive FDA 510(k) clearance?

CARE PAL, MODEL CPW-10X received FDA 510(k) clearance on 2009-08-21, under 510(k) number K091430.

Who is the listed applicant for CARE PAL, MODEL CPW-10X?

The FDA 510(k) record lists Digio2 International Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARE PAL, MODEL CPW-10X?

The FDA product code for CARE PAL, MODEL CPW-10X is DRG.

Related Clinical Trials

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Other records listing Digio2 International 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.

K112189THERMO PAL INFRARED EAR THERMOMETER

Related Devices (Code: DRG)

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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