510(k) K032593

MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER by Mercury Medical — Product Code BXR

K032593 is an FDA 510(k) premarket notification submitted by Mercury Medical for the device "MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER". The FDA issued a decision of Substantially Equivalent on February 3, 2004. The device falls under product code BXR (Meter, Airway Pressure (Inspiratory Force)), a Class II device regulated under 21 CFR 868.1780. Mercury Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 3, 2004
Date Received: August 22, 2003
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Meter, Airway Pressure (Inspiratory Force)
Device Class: Class II
Regulation Number: 868.1780
Review Panel: AN
Submission Type

Other clearances by Mercury Medical

K142096 — T-PIECE RESUSCITATOR (October 17, 2014)
K093913 — MERCURY MEDICAL T-PIECE RESUSCITATOR (April 6, 2010)
K090710 — MERCURY CPAP (August 20, 2009)
K083056 — NEO-STAT CO2 <KG (February 23, 2009)
K031814 — STATCO2METER, MODEL 10-55372 (August 14, 2003)
K031411 — MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 (July 30, 2003)
K021576 — MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 (November 4, 2002)
K001714 — MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149 (November 3, 2000)
K000073 — MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA (March 1, 2000)
K970756 — MERCURY MEDICAL REUSABLE CPR BAG (October 31, 1997)

510(k) K032593

Clearance Details

Device Classification

Other clearances by Mercury Medical

Other clearances for product code BXR

FDA data resources