Product code FCO— Gastroenterology, Urology
NCE REPLACEMENT BATTERIES
- Classification name
- Box, Battery, Rechargeable
- Device class
- Class 1
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 20
- First cleared
- Most recent
Market context for product code FCO
FDA has cleared devices under product code FCO between 1993 and 1995, filed by 3 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1995
- 1994
- 1993
Top applicants under product code FCO
Recent clearances under product code FCO
- K946080 — PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR
- K944348 — R&D BATTERIES, INC. PART NO. 5128, 5053, 5007
- K944388 — R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100
- K944389 — R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153
- K945870 — R&D PART NOS. 5490, 5541, 5358, 5497
- K944521 — RECHARGEABLE BATTERIES
- K945868 — R&D PART NOS. 5262, 5543, 5432, 5469
- K944387 — R&D BATTERIES PART NOS. 5186 AND 5230
- K944390 — R&D BATTERIES PART NOS. 5141, 5067, 5118, 5277
- K945869 — R&D PART NOS. 5443, 5322, 5448, 5492
- K945871 — R&D PART NOS. 5339, 5510, 5514
- K944294 — R&D BATTERIES, INC. PART NUMBERS 5162, 5040, 5237, AND 5102
- K944386 — R&D BATTERIES PART NOS. 5354 AND 5150
- K945867 — R&D PART 5518, 5306, 5315 AND 5457
- K943632 — REPLACEMENT BATTERIES
- K943680 — NCE REPLACEMENT BATTERIES
- K942018 — R&D BATTERIES, PART NO. 5025, 5128 AND 5183
- K933449 — R AND D BATTERIES, INC. PART NUMBER 5017
- K935472 — R & D BATTERIES, INC. PART NUMBER 5047
- K934683 — R AND D BATERIES
Data sourced from openFDA. This site is unofficial and independent of the FDA.