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FDA 510(k)

ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)

K-Number: K112830 · 2012-11-13

ApplicantNoninvasive Medical Technologies, Inc.
Decision Date2012-11-13
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) is the device name listed in this FDA 510(k) record. The listed applicant is Noninvasive Medical Technologies, Inc.. It received FDA 510(k) clearance on 2012-11-13 under 510(k) number K112830. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)?

ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) is a medical device that received FDA 510(k) clearance on 2012-11-13. The listed applicant is Noninvasive Medical Technologies, Inc.. The 510(k) number is K112830.

When did ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) receive FDA 510(k) clearance?

ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) received FDA 510(k) clearance on 2012-11-13, under 510(k) number K112830.

Who is the listed applicant for ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)?

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

What is the FDA product code for ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)?

The FDA product code for ZOEFLUID STATUS MONITOR (MODEL ZOE 2B) is DSB.

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 Noninvasive Medical Technologies, Inc. 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.

K131509ZOE FLUID STATUS MONITOR

Related Devices (Code: DSB)

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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