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510(k) K861330

SECHRIST AIRWAY PRESSURE MONITOR MODEL 600 by Sechrist Industries, Inc. — Product Code CAP

K861330 is an FDA 510(k) premarket notification submitted by Sechrist Industries, Inc. for the device "SECHRIST AIRWAY PRESSURE MONITOR MODEL 600". The FDA issued a decision of Substantially Equivalent on April 11, 1986. 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. Sechrist Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 1986
Date Received
April 9, 1986
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 Sechrist Industries, Inc.

  • K140559 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (May 30, 2014)
  • K100268 — SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (April 26, 2010)
  • K052713 — MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER (October 28, 2005)
  • K023745 — SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G (January 17, 2003)
  • K993167 — MILLENNIUM INFANT VENTILATOR (November 10, 1999)
  • K992503 — SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES (August 10, 1999)
  • K950386 — MODEL 3200P/3200PR HYPERBARIC CHAMBER (June 13, 1995)
  • K934164 — MODEL 2500E/2500ER HYPERBARIC CHAMBER (June 13, 1995)
  • K930713 — THE INFANT FLOW SYSTEM (September 16, 1993)
  • K914607 — SEHRIST VOLUME VENTILATOR, MODEL 2200B (November 2, 1992)

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)

FDA data resources