510(k) K801063

HALL ARTERIAL OSCILLATOR by American Sterilizer Co. — Product Code DWX

K801063 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "HALL ARTERIAL OSCILLATOR". The FDA issued a decision of Substantially Equivalent on September 26, 1980. The device falls under product code DWX (Stripper, Artery, Intraluminal), a Class II device regulated under 21 CFR 870.4875. American Sterilizer Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1980
Date Received
May 6, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stripper, Artery, Intraluminal
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type