510(k) K930791

AMERICAN POWER CONVERSIONS, BACK-UPS 600 by Bio Clinic Co. — Product Code FMF

K930791 is an FDA 510(k) premarket notification submitted by Bio Clinic Co. for the device "AMERICAN POWER CONVERSIONS, BACK-UPS 600". The FDA issued a decision of Substantially Equivalent on August 6, 1993. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Bio Clinic Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1993
Date Received
February 16, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type