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510(k) K122077

MANOMETER by Intersurgical, Inc. — Product Code CAP

K122077 is an FDA 510(k) premarket notification submitted by Intersurgical, Inc. for the device "MANOMETER". The FDA issued a decision of Substantially Equivalent on January 10, 2013. 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. Intersurgical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2013
Date Received
July 16, 2012
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 Intersurgical, Inc.

  • K223258 — TNI Clear-Guard™ 3 angled breathing filter (1545020) (June 15, 2023)
  • K122075 — DISPOSABLE GAS SAMPLING LINE WITH AND WITHOUT IN-LINE FILTER (December 20, 2012)
  • K121026 — FLO-GUARD BREATHING FILTER (November 2, 2012)
  • K092451 — INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTE (October 29, 2010)
  • K092129 — INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2 (May 18, 2010)
  • K092409 — HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD (March 10, 2010)
  • K032322 — CLEAR-THERM MICRO HME, MODEL 1441 (May 13, 2004)
  • K024270 — CLEAR-THERM 3 HMEF, CLEAR-THERM 3 WITH SUPERSET CATHETER MOUNT,CLEAR-THERM WITH (June 24, 2003)
  • K990949 — CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W (June 15, 1999)
  • K983610 — CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MIN (April 30, 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)
  • 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