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FDA 510(k)

HEATED SERVO HUMIDIFIER, MODEL HDS 2

K-Number: K893122 · 1989-10-20

ApplicantLifetronics, Inc.
Decision Date1989-10-20
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HEATED SERVO HUMIDIFIER, MODEL HDS 2 is the device name listed in this FDA 510(k) record. The listed applicant is Lifetronics, Inc.. It received FDA 510(k) clearance on 1989-10-20 under 510(k) number K893122. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEATED SERVO HUMIDIFIER, MODEL HDS 2?

HEATED SERVO HUMIDIFIER, MODEL HDS 2 is a medical device that received FDA 510(k) clearance on 1989-10-20. The listed applicant is Lifetronics, Inc.. The 510(k) number is K893122.

When did HEATED SERVO HUMIDIFIER, MODEL HDS 2 receive FDA 510(k) clearance?

HEATED SERVO HUMIDIFIER, MODEL HDS 2 received FDA 510(k) clearance on 1989-10-20, under 510(k) number K893122.

Who is the listed applicant for HEATED SERVO HUMIDIFIER, MODEL HDS 2?

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

What is the FDA product code for HEATED SERVO HUMIDIFIER, MODEL HDS 2?

The FDA product code for HEATED SERVO HUMIDIFIER, MODEL HDS 2 is BTT.

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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.

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