510(k) K800554

MULTI-FORMAT SFD MODEL 1720 by Philips Medical Systems (Cleveland), Inc. — Product Code IXL

K800554 is an FDA 510(k) premarket notification submitted by Philips Medical Systems (Cleveland), Inc. for the device "MULTI-FORMAT SFD MODEL 1720". The FDA issued a decision of Substantially Equivalent on April 10, 1980. The device falls under product code IXL (Device, Spot-Film), a Class II device regulated under 21 CFR 892.1670. Philips Medical Systems (Cleveland), Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1980
Date Received
March 12, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Spot-Film
Device Class
Class II
Regulation Number
892.1670
Review Panel
RA
Submission Type