FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211
K Number: K934660
·
Decision Dec 3, 1993
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
193
Applicant Total
53
Review Days
66
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Basic Information
- Device Name
- R AND D BATTERIES, INC. PART NUMBERS 5310, 5063 & 5211
- K Number
- K934660
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- R & D Batteries, Inc.
- Date Received
- September 28, 1993
- Decision Date
- December 3, 1993
- Product Code
- DSH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | FDA class 2 | Cardiovascular |
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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 |
| K951282 | R&D BATTERIES, INC. PART NUMBERS 5039, 5052, 5056 AND 5061 | Aug 18, 1995 | Substantially Equivalent |
| K951284 | R&D BATTERIES, INC. PART NUMBERS 5137, 5140, 5142 AND 5155 | Aug 18, 1995 | Substantially Equivalent |
| K951402 | R&D BATTERIES PART NOS. 5167, 5221, 5244 AND 5247 | Aug 18, 1995 | Substantially Equivalent |
| K951281 | R&D BATTERIS, INC. PART NUMBER 5024, 5027, 5033 AND 5035 | Aug 18, 1995 | Substantially Equivalent |
| K951276 | R&D BATTERIES, INC. PART NUMBERS 5412, 5420, 5436 AND 5438 | Aug 18, 1995 | Substantially Equivalent |
| K951279 | R&D BATTEERIES, INC. PART NUMBERS 5173, 5178, 5197 AND 5199 | Aug 18, 1995 | Substantially Equivalent |
| K951399 | R&D BATTERIES PART NOS. 5041 & 5655 | Aug 18, 1995 | Substantially Equivalent |
| K951274 | R&D BATTRIES, INC. PART NUMBERS 5601, 5602, 5624 AND 5626 | Aug 18, 1995 | Substantially Equivalent |
| K951404 | R&D BATTERIES PART NOS. 5096, 5115, 5128 AND 5131 | Aug 18, 1995 | Substantially Equivalent |