FCO — Box, Battery, Rechargeable Class I

FDA Device Classification

Classification Details

Product Code
FCO
Device Class
Class I
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K946080portable power systemsPHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATORAugust 2, 1995
K944388r and d batteriesR&D BATTERIES PART NOS. 5116, 5124, 5099, 5100March 23, 1995
K945870r and d batteriesR&D PART NOS. 5490, 5541, 5358, 5497March 23, 1995
K944348r and d batteriesR&D BATTERIES, INC. PART NO. 5128, 5053, 5007March 23, 1995
K944389r and d batteriesR&D BATTERIES PART NOS. 5111, 5112, 5065, 5153March 23, 1995
K944521r and d batteriesRECHARGEABLE BATTERIESMarch 6, 1995
K945868r and d batteriesR&D PART NOS. 5262, 5543, 5432, 5469March 6, 1995
K944387r and d batteriesR&D BATTERIES PART NOS. 5186 AND 5230March 2, 1995
K945871r and d batteriesR&D PART NOS. 5339, 5510, 5514February 27, 1995
K945869r and d batteriesR&D PART NOS. 5443, 5322, 5448, 5492February 27, 1995
K944390r and d batteriesR&D BATTERIES PART NOS. 5141, 5067, 5118, 5277February 27, 1995
K944294r and d batteriesR&D BATTERIES, INC. PART NUMBERS 5162, 5040, 5237, AND 5102December 30, 1994
K944386r and d batteriesR&D BATTERIES PART NOS. 5354 AND 5150December 30, 1994
K945867r and d batteriesR&D PART 5518, 5306, 5315 AND 5457December 29, 1994
K943632national custom entREPLACEMENT BATTERIESNovember 4, 1994
K943680national custom entNCE REPLACEMENT BATTERIESNovember 4, 1994
K942018r and d batteriesR&D BATTERIES, PART NO. 5025, 5128 AND 5183July 25, 1994
K933449r and d batteriesR AND D BATTERIES, INC. PART NUMBER 5017March 1, 1994
K935472r and d batteriesR & D BATTERIES, INC. PART NUMBER 5047February 25, 1994
K934683r and d batteriesR AND D BATERIESNovember 22, 1993