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FDA 510(k)

THERMO-STAT SYSTEM

K-Number: K970367 · 1997-12-17

ApplicantAquarius Medical Corp.
Decision Date1997-12-17
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THERMO-STAT SYSTEM 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 1997-12-17 under 510(k) number K970367. 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 THERMO-STAT SYSTEM?

THERMO-STAT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-12-17. The listed applicant is Aquarius Medical Corp.. The 510(k) number is K970367.

When did THERMO-STAT SYSTEM receive FDA 510(k) clearance?

THERMO-STAT SYSTEM received FDA 510(k) clearance on 1997-12-17, under 510(k) number K970367.

Who is the listed applicant for THERMO-STAT SYSTEM?

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 THERMO-STAT SYSTEM?

The FDA product code for THERMO-STAT SYSTEM is DWJ.

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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.

K003368ACROTHERMK954964AQUACENTER 2000 SYSTEM

Related Devices (Code: DWJ)

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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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