510(k) K913076

I.V. INSTANT TIMER by The Master Medical Corp. — Product Code FPA

K913076 is an FDA 510(k) premarket notification submitted by The Master Medical Corp. for the device "I.V. INSTANT TIMER". The FDA issued a decision of Substantially Equivalent on October 17, 1991. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. The Master Medical Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1991
Date Received
July 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type