R&D Part Nos. 5490, 5541, 5358, 5497
FDA 510(k) K945870 · R & D Batteries, Inc.
510(k) numberK945870
Submission
- Device name
- R&D Part Nos. 5490, 5541, 5358, 5497
- Applicant
- R & D Batteries, Inc.
Burnsville, MN, US - Received
- December 1, 1994
- Decision date
- March 23, 1995
- 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 |
| 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 |
| K944390 | R&D Batteries Part Nos. 5141, 5067, 5118, 5277FCO · Traditional | R & D Batteries, Inc. | 02/27/1995SE |
More from R & D Batteries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K141795 | Batter Pack, Replacement for Physio Control Lifepak 500MKJ · Traditional | 12/08/2014SE |
| K951404 | R&D Batteries Part Nos. 5096, 5115, 5128 and 5131FLL · Traditional | 08/18/1995SE |
| K951403 | R&D Batteries Part Nos. 5164, 5252, 5634 and 5650FLL · Traditional | 08/18/1995SE |
| K951402 | R&D Batteries Part Nos. 5167, 5221, 5244 and 5247FLL · Traditional | 08/18/1995SE |
| K951401 | R&D Batteries Part Nos. 5015, 5016, 5037 and 5051FLL · Traditional | 08/18/1995SE |
| K951400 | R&D Batteries Part Nos. 5064, 5157, 5489 and 5536FLL · Traditional | 08/18/1995SE |
| K951399 | R&D Batteries Part Nos. 5041 & 5655FLL · Traditional | 08/18/1995SE |
| K951285 | R&D Batteries, Inc. Part Numbers 5158, 5168, 5171 and 5172FLL · Traditional | 08/18/1995SE |
| K951284 | R&D Batteries, Inc. Part Numbers 5137, 5140, 5142 and 5155FLL · Traditional | 08/18/1995SE |
| K951283 | R&D Batteries, Inc. Part Numbers 5075-B, 5076, 5122 and 5123FLL · Traditional | 08/18/1995SE |
Questions and answers
When was R&D Part Nos. 5490, 5541, 5358, 5497 cleared by the FDA?
R&D Part Nos. 5490, 5541, 5358, 5497 (K945870) received a 510(k) decision of Substantially Equivalent on March 23, 1995, 112 days after the submission was received.
What is the product code of K945870?
The FDA product code is FCO – Box, Battery, Rechargeable, a Class I (low risk) device regulated under 21 CFR 876.1500.