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510(k) K022402

DISPOSABLE PRESSURE MANOMETER by Vital Signs, Inc. — Product Code CAP

K022402 is an FDA 510(k) premarket notification submitted by Vital Signs, Inc. for the device "DISPOSABLE PRESSURE MANOMETER". The FDA issued a decision of Substantially Equivalent on August 22, 2002. 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. Vital Signs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2002
Date Received
July 23, 2002
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 Vital Signs, Inc.

  • K112902 — ENFLOW IV FLUID WARMER (March 14, 2012)
  • K041309 — IMASK TM (June 30, 2004)
  • K030985 — BREAS PV 10I CPAP SYSTEM, MODEL PV 10I (October 15, 2003)
  • K021315 — SURE-LOK (August 21, 2002)
  • K002454 — BREAS HA50 HUMIDIFIER, MODEL HA50 (March 7, 2001)
  • K001553 — BREAS PV 100 CPAP SYSTEM (August 3, 2000)
  • K000441 — BODYGUARD (April 11, 2000)
  • K994044 — CLEEN-ABLE (February 25, 2000)
  • K990412 — CUFF-ABLE PLUS (September 1, 1999)
  • K984468 — VITAL PEP (June 1, 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)

FDA data resources