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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 the device name listed in this FDA 510(k) record. The listed applicant is Prior Care Science Technology, Ltd.. It received FDA 510(k) clearance on 2025-08-28 under 510(k) 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. The listed applicant is Prior Care Science Technology, Ltd.. The 510(k) number is K250148.

When did Medical Gas Analyzer (AG200) receive FDA 510(k) clearance?

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

Who is the listed applicant for Medical Gas Analyzer (AG200)?

The FDA 510(k) record lists Prior Care Science Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.K240937AIM (N/A)Inventeur, LLC

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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