Nce Replacement Batteries
FDA 510(k) K943680 · National Custom Ent., Inc.
510(k) numberK943680
Submission
- Device name
- Nce Replacement Batteries
- Applicant
- National Custom Ent., Inc.
Burnsville, MN, US - Received
- July 26, 1994
- Decision date
- November 4, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FCO – Box, Battery, Rechargeable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FCO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K946080 | Physio Control Lifepak 200 Auto DefibrillatorFCO · Traditional | Portable Power Systems, Inc. | 08/02/1995SE |
| K945870 | R&D Part Nos. 5490, 5541, 5358, 5497FCO · Traditional | R & D Batteries, Inc. | 03/23/1995SE |
| K944389 | R&D Batteries Part Nos. 5111, 5112, 5065, 5153FCO · Traditional | R & D Batteries, Inc. | 03/23/1995SE |
| K944388 | R&D Batteries Part Nos. 5116, 5124, 5099, 5100FCO · Traditional | R & D Batteries, Inc. | 03/23/1995SE |
| K944348 | R&D Batteries, Inc. Part No. 5128, 5053, 5007FCO · Traditional | R & D Batteries, Inc. | 03/23/1995SE |
| K945868 | R&D Part Nos. 5262, 5543, 5432, 5469FCO · Traditional | R & D Batteries, Inc. | 03/06/1995SE |
| K944521 | Rechargeable BatteriesFCO · Traditional | R & D Batteries, Inc. | 03/06/1995SE |
| K944387 | R&D Batteries Part Nos. 5186 and 5230FCO · Traditional | R & D Batteries, Inc. | 03/02/1995SE |
| K945871 | R&D Part Nos. 5339, 5510, 5514FCO · Traditional | R & D Batteries, Inc. | 02/27/1995SE |
| K945869 | R&D Part Nos. 5443, 5322, 5448, 5492FCO · Traditional | R & D Batteries, Inc. | 02/27/1995SE |
More from R & D Batteries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K012264 | Marquette MAC8, Mac Personal, Mac Stress, Model N3043IWCDPS · Traditional | 10/10/2001SE |
| K012263 | Marquette Eagle Monitor Model 4000, Model N3024DPS · Traditional | 10/10/2001SE |
| K012266 | Sherwood 224, 324 Feeding Pump & K524 Intri-Flush, Model N7213IWC2MRZ · Traditional | 09/12/2001SE |
| K012262 | Baxter AS40A, AS41 Syringe Pump, Model N61WCMRZ · Traditional | 09/12/2001SE |
| K012259 | Medfusion 2001 & 2010, Model N7215IWCMRZ · Traditional | 09/12/2001SE |
| K012229 | Scale-Tronix 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C &…FMT · Traditional | 09/10/2001SE |
| K943632 | Replacement BatteriesFCO · Traditional | 11/04/1994SE |
| K942629 | Nce Replacement BatteriesDPS · Traditional | 08/18/1994SE |
| K941995 | Nce Replacement BatteriesLDD · Traditional | 07/26/1994ST |
| K942244 | Replacement Batteries/Welch Allyn #72200 Power HandleERA · Traditional | 06/24/1994SE |
Questions and answers
When was Nce Replacement Batteries cleared by the FDA?
Nce Replacement Batteries (K943680) received a 510(k) decision of Substantially Equivalent on November 4, 1994, 101 days after the submission was received.
What is the product code of K943680?
The FDA product code is FCO – Box, Battery, Rechargeable, a Class I (low risk) device regulated under 21 CFR 876.1500.