FCO — Box, Battery, Rechargeable Class I
FDA product code FCO covers "Box, Battery, Rechargeable", a Class I medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K946080 | portable power systems | PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR | August 2, 1995 |
| K944388 | r and d batteries | R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100 | March 23, 1995 |
| K944348 | r and d batteries | R&D BATTERIES, INC. PART NO. 5128, 5053, 5007 | March 23, 1995 |
| K945870 | r and d batteries | R&D PART NOS. 5490, 5541, 5358, 5497 | March 23, 1995 |
| K944389 | r and d batteries | R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153 | March 23, 1995 |
| K944521 | r and d batteries | RECHARGEABLE BATTERIES | March 6, 1995 |
| K945868 | r and d batteries | R&D PART NOS. 5262, 5543, 5432, 5469 | March 6, 1995 |
| K944387 | r and d batteries | R&D BATTERIES PART NOS. 5186 AND 5230 | March 2, 1995 |
| K945871 | r and d batteries | R&D PART NOS. 5339, 5510, 5514 | February 27, 1995 |
| K944390 | r and d batteries | R&D BATTERIES PART NOS. 5141, 5067, 5118, 5277 | February 27, 1995 |
| K945869 | r and d batteries | R&D PART NOS. 5443, 5322, 5448, 5492 | February 27, 1995 |
| K944294 | r and d batteries | R&D BATTERIES, INC. PART NUMBERS 5162, 5040, 5237, AND 5102 | December 30, 1994 |
| K944386 | r and d batteries | R&D BATTERIES PART NOS. 5354 AND 5150 | December 30, 1994 |
| K945867 | r and d batteries | R&D PART 5518, 5306, 5315 AND 5457 | December 29, 1994 |
| K943680 | national custom ent | NCE REPLACEMENT BATTERIES | November 4, 1994 |
| K943632 | national custom ent | REPLACEMENT BATTERIES | November 4, 1994 |
| K942018 | r and d batteries | R&D BATTERIES, PART NO. 5025, 5128 AND 5183 | July 25, 1994 |
| K933449 | r and d batteries | R AND D BATTERIES, INC. PART NUMBER 5017 | March 1, 1994 |
| K935472 | r and d batteries | R & D BATTERIES, INC. PART NUMBER 5047 | February 25, 1994 |
| K934683 | r and d batteries | R AND D BATERIES | November 22, 1993 |