FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RECHARGEABLE BATTERIES
K Number: K944521
·
Decision Mar 6, 1995
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
19
Applicant Total
53
Review Days
171
Basic Information
- Device Name
- RECHARGEABLE BATTERIES
- K Number
- K944521
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- R & D BATTERIES, INC.
- Date Received
- September 16, 1994
- Decision Date
- March 6, 1995
- Product Code
- FCO
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FCO | Box, Battery, Rechargeable | FDA class 1 | Gastroenterology, Urology |
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Other Clearances by R & D BATTERIES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K141795 | BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 | Dec 8, 2014 | Substantially Equivalent |
| K951277 | R&D BATTERIES, INC. PART NUMBERS 5295, 5334, 5344 AND 5410 | Aug 18, 1995 | Substantially Equivalent |
| K951281 | R&D BATTERIS, INC. PART NUMBER 5024, 5027, 5033 AND 5035 | Aug 18, 1995 | Substantially Equivalent |
| K951274 | R&D BATTRIES, INC. PART NUMBERS 5601, 5602, 5624 AND 5626 | Aug 18, 1995 | Substantially Equivalent |
| K951403 | R&D BATTERIES PART NOS. 5164, 5252, 5634 AND 5650 | Aug 18, 1995 | Substantially Equivalent |
| K951282 | R&D BATTERIES, INC. PART NUMBERS 5039, 5052, 5056 AND 5061 | Aug 18, 1995 | Substantially Equivalent |
| K951278 | R&D BATTERIES, INC. PART NUMBERS 5213, 5222, 5268 AND 5284 | Aug 18, 1995 | Substantially Equivalent |
| K951285 | R&D BATTERIES, INC. PART NUMBERS 5158, 5168, 5171 AND 5172 | Aug 18, 1995 | Substantially Equivalent |
| K951276 | R&D BATTERIES, INC. PART NUMBERS 5412, 5420, 5436 AND 5438 | Aug 18, 1995 | Substantially Equivalent |
| K951275 | R&D BATTERIES, INC. PART NUMBERS 5453, 5474, 5513 AND 5595 | Aug 18, 1995 | Substantially Equivalent |