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510(k) K172284

NAPA LP-15 Airway Pressure Monitor by Drw Medical, LLC — Product Code CAP

K172284 is an FDA 510(k) premarket notification submitted by Drw Medical, LLC for the device "NAPA LP-15 Airway Pressure Monitor". The FDA issued a decision of Substantially Equivalent on February 9, 2018. The device falls under product code CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm)), a Class II device regulated under 21 CFR 868.2600. Drw Medical, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2018
Date Received
July 28, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Device Class
Class II
Regulation Number
868.2600
Review Panel
AN
Submission Type

Other clearances by Drw Medical, LLC

  • K221676 — Exsalta (September 16, 2022)

Other clearances for product code CAP

  • K201666 — SINGLE USE MANOMETER (November 13, 2020)
  • K182292 — VORTRAN APM-Plus (September 18, 2019)
  • K180510 — NS 120P-TRS Airway Pressure Gauge (May 1, 2019)
  • K153733 — VORTRAN Manometer (September 16, 2016)
  • K143148 — Disposable Pressure Manometer (DPM) (August 11, 2015)
  • K140370 — DISPOSABLE PRESSURE MANOMETER (June 19, 2014)
  • K122627 — GIO DIGITAL PRESSURE GUAGES (August 22, 2013)
  • K122077 — MANOMETER (January 10, 2013)
  • K120118 — VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER (May 24, 2012)
  • K103639 — VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (V (September 15, 2011)

FDA data resources