510(k) K945870
- Device
- R&D PART NOS. 5490, 5541, 5358, 5497
- Applicant
- R & D BATTERIES, INC.
- 510(k) number
- K945870
- Product code
- FCO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-03-23
- Date received
- 1994-12-01
- Regulation
- 876.1500
- Classification name
- Box, Battery, Rechargeable
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RANDALL C NODDINGS
- Address
- P.O. Box 5007 Burnsville MN US 55337 55337
FDA Registration Numbers#
- 3011137372
- 3010041511
- 2132111
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FCO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K946080 | PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR | Portable Power Systems, Inc. | 1995-08-02 |
| K944388 | R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100 | R & D Batteries, Inc. | 1995-03-23 |
| K944389 | R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153 | R & D Batteries, Inc. | 1995-03-23 |
| K944348 | R&D BATTERIES, INC. PART NO. 5128, 5053, 5007 | R & D Batteries, Inc. | 1995-03-23 |
| K944521 | RECHARGEABLE BATTERIES | R & D Batteries, Inc. | 1995-03-06 |
| K945868 | R&D PART NOS. 5262, 5543, 5432, 5469 | R & D Batteries, Inc. | 1995-03-06 |
| K944387 | R&D BATTERIES PART NOS. 5186 AND 5230 | R & D Batteries, Inc. | 1995-03-02 |
| K944390 | R&D BATTERIES PART NOS. 5141, 5067, 5118, 5277 | R & D Batteries, Inc. | 1995-02-27 |
| K945869 | R&D PART NOS. 5443, 5322, 5448, 5492 | R & D Batteries, Inc. | 1995-02-27 |
| K945871 | R&D PART NOS. 5339, 5510, 5514 | R & D Batteries, Inc. | 1995-02-27 |
| K944294 | R&D BATTERIES, INC. PART NUMBERS 5162, 5040, 5237, AND 5102 | R & D Batteries, Inc. | 1994-12-30 |
| K944386 | R&D BATTERIES PART NOS. 5354 AND 5150 | R & D Batteries, Inc. | 1994-12-30 |
| K945867 | R&D PART 5518, 5306, 5315 AND 5457 | R & D Batteries, Inc. | 1994-12-29 |
| K943680 | NCE REPLACEMENT BATTERIES | National Custom Ent., Inc. | 1994-11-04 |
| K943632 | REPLACEMENT BATTERIES | National Custom Ent., Inc. | 1994-11-04 |
Legacy Summary#
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FDA Review#
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