510(k) K140370

DISPOSABLE PRESSURE MANOMETER by Besmed Health Business Corp — Product Code CAP

K140370 is an FDA 510(k) premarket notification submitted by Besmed Health Business Corp for the device "DISPOSABLE PRESSURE MANOMETER". The FDA issued a decision of Substantially Equivalent on June 19, 2014. 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. Besmed Health Business Corp has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2014
Date Received
February 14, 2014
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