Home / 510(k) Clearances / K003497

510(k) K003497

DISPOSABLE PRESSURE MONITOR by Engineered Medical Systems — Product Code CAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2000
Date Received
November 13, 2000
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 Engineered Medical Systems

  • K220533 — Endoscopy Oxygen Mask (November 16, 2022)
  • K062104 — TALKING TRACH (April 20, 2007)
  • K023683 — MULTI-STRAP FULL FACE MASK (December 1, 2003)
  • K013728 — TRACH VOX (July 30, 2002)
  • K013122 — EMS ELECTROSTATIC FLITER AND HME COMBINATION (April 19, 2002)
  • K013123 — EMS PULMONARY FUNCTION TESTING FILTER (March 14, 2002)
  • K013089 — EMS HEPA FILTER AND HME COMBINATIONS (March 14, 2002)
  • K000215 — SWIVEL ELBOW (May 26, 2000)
  • K000314 — INCENTIVE SPIROMETER (April 12, 2000)
  • K991955 — MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH C (July 6, 1999)

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)
  • K172284 — NAPA LP-15 Airway Pressure Monitor (February 9, 2018)
  • 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)