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FDA 510(k)

Precise Position

K-Number: K203514 · 2021-06-17

Decision Date2021-06-17
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Precise Position is a medical device manufactured by Philips Healthcare (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-06-17 under approval 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. It is manufactured by Philips Healthcare (Suzhou) Co., Ltd.. The 510(k) number is K203514.

When was Precise Position approved by the FDA?

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

What company makes Precise Position?

Precise Position is manufactured by Philips Healthcare (Suzhou) Co., Ltd..

What is the FDA product code for Precise Position?

The FDA product code for Precise Position is JAK.

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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.