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FDA 510(k)

Level 1 Convective Warmer

K-Number: K181699 · 2018-07-26

ApplicantSmiths Medical Asd, Inc.
Decision Date2018-07-26
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Level 1 Convective Warmer is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2018-07-26 under 510(k) number K181699. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Level 1 Convective Warmer?

Level 1 Convective Warmer is a medical device that received FDA 510(k) clearance on 2018-07-26. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K181699.

When did Level 1 Convective Warmer receive FDA 510(k) clearance?

Level 1 Convective Warmer received FDA 510(k) clearance on 2018-07-26, under 510(k) number K181699.

Who is the listed applicant for Level 1 Convective Warmer?

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

What is the FDA product code for Level 1 Convective Warmer?

The FDA product code for Level 1 Convective Warmer is DWJ.

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Related Devices (Code: DWJ)

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.

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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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