510(k) K180510

NS 120P-TRS Airway Pressure Gauge by Instrumentation Industries, Inc. — Product Code CAP

K180510 is an FDA 510(k) premarket notification submitted by Instrumentation Industries, Inc. for the device "NS 120P-TRS Airway Pressure Gauge". The FDA issued a decision of Substantially Equivalent on May 1, 2019. 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. Instrumentation Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2019
Date Received
February 27, 2018
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