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FDA 510(k)

Medical Gas Analyzer (AG200)

K-Number: K250148 · 2025-08-28

ApplicantPrior Care Science Technology, Ltd.
Decision Date2025-08-28
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Medical Gas Analyzer (AG200) is a medical device manufactured by Prior Care Science Technology, Ltd.. It received FDA 510(k) clearance on 2025-08-28 under approval number K250148. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medical Gas Analyzer (AG200)?

Medical Gas Analyzer (AG200) is a medical device that received FDA 510(k) clearance on 2025-08-28. It is manufactured by Prior Care Science Technology, Ltd.. The 510(k) number is K250148.

When was Medical Gas Analyzer (AG200) approved by the FDA?

Medical Gas Analyzer (AG200) received FDA 510(k) clearance on 2025-08-28, under approval number K250148.

What company makes Medical Gas Analyzer (AG200)?

Medical Gas Analyzer (AG200) is manufactured by Prior Care Science Technology, Ltd..

What is the FDA product code for Medical Gas Analyzer (AG200)?

The FDA product code for Medical Gas Analyzer (AG200) is CCK.

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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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