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FDA 510(k)

NT1D VITAL SIGNS MONITOR

K-Number: K123797 · 2013-08-27

ApplicantNew Tech, Inc.
Decision Date2013-08-27
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NT1D VITAL SIGNS MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is New Tech, Inc.. It received FDA 510(k) clearance on 2013-08-27 under 510(k) number K123797. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NT1D VITAL SIGNS MONITOR?

NT1D VITAL SIGNS MONITOR is a medical device that received FDA 510(k) clearance on 2013-08-27. The listed applicant is New Tech, Inc.. The 510(k) number is K123797.

When did NT1D VITAL SIGNS MONITOR receive FDA 510(k) clearance?

NT1D VITAL SIGNS MONITOR received FDA 510(k) clearance on 2013-08-27, under 510(k) number K123797.

Who is the listed applicant for NT1D VITAL SIGNS MONITOR?

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

What is the FDA product code for NT1D VITAL SIGNS MONITOR?

The FDA product code for NT1D VITAL SIGNS MONITOR is DQA.

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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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