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FDA 510(k)

Precise Position

K-Number: K203514 · 2021-06-17

ApplicantPhilips Healthcare (Suzhou) Co., Ltd.
Decision Date2021-06-17
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Precise Position is the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-06-17 under 510(k) number K203514. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precise Position?

Precise Position is a medical device that received FDA 510(k) clearance on 2021-06-17. The listed applicant is Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K203514.

When did Precise Position receive FDA 510(k) clearance?

Precise Position received FDA 510(k) clearance on 2021-06-17, under 510(k) number K203514.

Who is the listed applicant for Precise Position?

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

What is the FDA product code for Precise Position?

The FDA product code for Precise Position is JAK.

Other records listing Philips Healthcare (Suzhou) Co., Ltd. as applicant

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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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