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FDA 510(k)

VORTRAN Manometer

K-Number: K153733 · 2016-09-16

ApplicantVortran Medical Technology 1, Inc.
Decision Date2016-09-16
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VORTRAN Manometer is the device name listed in this FDA 510(k) record. The listed applicant is Vortran Medical Technology 1, Inc.. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K153733. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VORTRAN Manometer?

VORTRAN Manometer is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Vortran Medical Technology 1, Inc.. The 510(k) number is K153733.

When did VORTRAN Manometer receive FDA 510(k) clearance?

VORTRAN Manometer received FDA 510(k) clearance on 2016-09-16, under 510(k) number K153733.

Who is the listed applicant for VORTRAN Manometer?

The FDA 510(k) record lists Vortran Medical Technology 1, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VORTRAN Manometer?

The FDA product code for VORTRAN Manometer is CAP.

Other records listing Vortran Medical Technology 1, 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.

K202219VORTRAN GO2VENT with PEEP ValveK182292VORTRAN APM-PlusK173914VORTRAN Cuff Inflator (VCI)K162968VORTRAN GO2VENT

Related Devices (Code: CAP)

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.

K201666SINGLE USE MANOMETERFlexicare Medical Limited.K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLC

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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