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FDA 510(k)

ACROTHERM

K-Number: K003368 · 2001-01-19

ApplicantAquarius Medical Corp.
Decision Date2001-01-19
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACROTHERM is the device name listed in this FDA 510(k) record. The listed applicant is Aquarius Medical Corp.. It received FDA 510(k) clearance on 2001-01-19 under 510(k) number K003368. 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 ACROTHERM?

ACROTHERM is a medical device that received FDA 510(k) clearance on 2001-01-19. The listed applicant is Aquarius Medical Corp.. The 510(k) number is K003368.

When did ACROTHERM receive FDA 510(k) clearance?

ACROTHERM received FDA 510(k) clearance on 2001-01-19, under 510(k) number K003368.

Who is the listed applicant for ACROTHERM?

The FDA 510(k) record lists Aquarius Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACROTHERM?

The FDA product code for ACROTHERM is DWJ.

Related Clinical Trials

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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Other records listing Aquarius Medical Corp. as applicant

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.

K970367THERMO-STAT SYSTEMK954964AQUACENTER 2000 SYSTEM

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

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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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