NS 120P-TRS Airway Pressure Gauge

Monitor, Airway Pressure (includes Gauge And/or Alarm)

Instrumentation Industries, Inc.

The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Ns 120p-trs Airway Pressure Gauge.

Pre-market Notification Details

Device IDK180510
510k NumberK180510
Device Name:NS 120P-TRS Airway Pressure Gauge
ClassificationMonitor, Airway Pressure (includes Gauge And/or Alarm)
Applicant Instrumentation Industries, Inc. 2990 Industrial Blvd. Bethel Park,  PA  15102
ContactDoris Walter
CorrespondentDoris Walter
Instrumentation Industries, Inc. 2990 Industrial Blvd. Bethel Park,  PA  15102
Product CodeCAP  
CFR Regulation Number868.2600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-27
Decision Date2019-05-01

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