R AND D BATTERIES, INC. PART NOS. 5038 & 5347— 510(k) K933491
Substantially EquivalentR & D Batteries, Inc.
FDA 510(k) clearance K933491 for R AND D BATTERIES, INC. PART NOS. 5038 & 5347, Substantially Equivalent on 1993-11-19. Applicant: R & D Batteries, Inc.. Device class: 2.
Clearance details
- Applicant
- R & D Batteries, Inc.
- Product code
- Code ETN
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burnsville, MN, US
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More clearances from R & D Batteries, Inc.
view all- K141795 — BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500
- K951274 — R&D BATTRIES, INC. PART NUMBERS 5601, 5602, 5624 AND 5626
- K951275 — R&D BATTERIES, INC. PART NUMBERS 5453, 5474, 5513 AND 5595
- K951276 — R&D BATTERIES, INC. PART NUMBERS 5412, 5420, 5436 AND 5438
- K951277 — R&D BATTERIES, INC. PART NUMBERS 5295, 5334, 5344 AND 5410
Adverse events under product code ETN
product code ETN- Death
- 7
- Injury
- 327
- Malfunction
- 2,776
- Total
- 3,110
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.