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FDA 510(k)

IHEALTH FINGERTIP PULSE OXIMETER

K-Number: K131111 · 2013-09-11

ApplicantAndon Health Co, Ltd.
Decision Date2013-09-11
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

IHEALTH FINGERTIP PULSE OXIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2013-09-11 under 510(k) number K131111. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IHEALTH FINGERTIP PULSE OXIMETER?

IHEALTH FINGERTIP PULSE OXIMETER is a medical device that received FDA 510(k) clearance on 2013-09-11. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K131111.

When did IHEALTH FINGERTIP PULSE OXIMETER receive FDA 510(k) clearance?

IHEALTH FINGERTIP PULSE OXIMETER received FDA 510(k) clearance on 2013-09-11, under 510(k) number K131111.

Who is the listed applicant for IHEALTH FINGERTIP PULSE OXIMETER?

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

What is the FDA product code for IHEALTH FINGERTIP PULSE OXIMETER?

The FDA product code for IHEALTH FINGERTIP PULSE OXIMETER is DQA.

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Related Devices (Code: DQA)

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

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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