BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500— 510(k) K141795
Substantially EquivalentR & D Batteries, Inc.
FDA 510(k) clearance K141795 for BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500, Substantially Equivalent on 2014-12-08. Applicant: R & D Batteries, Inc.. Device class: 3.
Clearance details
- Applicant
- R & D Batteries, Inc.
- Product code
- Code MKJ
- Device class
- Class 3
- Regulation
- 21 CFR 870.5310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castle Rock, CO, US
Recent devices under product code MKJ
view allMore clearances from R & D Batteries, Inc.
view all- 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
- K951278 — R&D BATTERIES, INC. PART NUMBERS 5213, 5222, 5268 AND 5284
Adverse events under product code MKJ
product code MKJ- Death
- 961
- Injury
- 1,070
- Malfunction
- 90,719
- Other
- 8
- Total
- 92,758
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.