510(k) K905208

MORSE ANESTHESIA by North American Instrument Corp. — Product Code FPA

K905208 is an FDA 510(k) premarket notification submitted by North American Instrument Corp. for the device "MORSE ANESTHESIA". The FDA issued a decision of Substantially Equivalent on January 10, 1992. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. North American Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1992
Date Received
November 20, 1990
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