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FDA 510(k)

A-LYTE® Integrated Multisensor (IMT Na K Cl)

K-Number: K222438 · 2023-07-25

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2023-07-25
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

A-LYTE® Integrated Multisensor (IMT Na K Cl) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-07-25 under 510(k) number K222438. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A-LYTE® Integrated Multisensor (IMT Na K Cl)?

A-LYTE® Integrated Multisensor (IMT Na K Cl) is a medical device that received FDA 510(k) clearance on 2023-07-25. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K222438.

When did A-LYTE® Integrated Multisensor (IMT Na K Cl) receive FDA 510(k) clearance?

A-LYTE® Integrated Multisensor (IMT Na K Cl) received FDA 510(k) clearance on 2023-07-25, under 510(k) number K222438.

Who is the listed applicant for A-LYTE® Integrated Multisensor (IMT Na K Cl)?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A-LYTE® Integrated Multisensor (IMT Na K Cl)?

The FDA product code for A-LYTE® Integrated Multisensor (IMT Na K Cl) is JGS.

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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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