510(k) K911888

PHILIPS ANGIOPRO by Philips Medical Systems North America, Inc. — Product Code IZP

K911888 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America, Inc. for the device "PHILIPS ANGIOPRO". The FDA issued a decision of Substantially Equivalent on October 15, 1991. The device falls under product code IZP (Programmer, Changer, Film/Cassette, Radiographic), a Class II device regulated under 21 CFR 892.1870. Philips Medical Systems North America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1991
Date Received
April 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Programmer, Changer, Film/Cassette, Radiographic
Device Class
Class II
Regulation Number
892.1870
Review Panel
RA
Submission Type