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FDA 510(k)

Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)

K-Number: K223100 · 2023-06-27

ApplicantMedline Industries, Inc.
Decision Date2023-06-27
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2023-06-27 under 510(k) number K223100. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)?

Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) is a medical device that received FDA 510(k) clearance on 2023-06-27. The listed applicant is Medline Industries, Inc.. The 510(k) number is K223100.

When did Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) receive FDA 510(k) clearance?

Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) received FDA 510(k) clearance on 2023-06-27, under 510(k) number K223100.

Who is the listed applicant for Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)?

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

What is the FDA product code for Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)?

The FDA product code for Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) is CAF.

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Official Source

View on FDA Database →

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