510(k) K873498

INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING by Dhd Medical Products Div. Diemolding Corp. — Product Code BXR

K873498 is an FDA 510(k) premarket notification submitted by Dhd Medical Products Div. Diemolding Corp. for the device "INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING". The FDA issued a decision of Substantially Equivalent on March 9, 1988. The device falls under product code BXR (Meter, Airway Pressure (Inspiratory Force)), a Class II device regulated under 21 CFR 868.1780. Dhd Medical Products Div. Diemolding Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1988
Date Received
August 31, 1987
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