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FDA 510(k)

NAPA LP-15 Airway Pressure Monitor

K-Number: K172284 · 2018-02-09

ApplicantDrw Medical, LLC
Decision Date2018-02-09
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NAPA LP-15 Airway Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Drw Medical, LLC. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K172284. 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 NAPA LP-15 Airway Pressure Monitor?

NAPA LP-15 Airway Pressure Monitor is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Drw Medical, LLC. The 510(k) number is K172284.

When did NAPA LP-15 Airway Pressure Monitor receive FDA 510(k) clearance?

NAPA LP-15 Airway Pressure Monitor received FDA 510(k) clearance on 2018-02-09, under 510(k) number K172284.

Who is the listed applicant for NAPA LP-15 Airway Pressure Monitor?

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

What is the FDA product code for NAPA LP-15 Airway Pressure Monitor?

The FDA product code for NAPA LP-15 Airway Pressure Monitor is CAP.

Other records listing Drw Medical, LLC 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.

K221676Exsalta

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.K153733VORTRAN ManometerVortran Medical Technology 1, Inc.

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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