R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 5050— 510(k) K935301
Substantially EquivalentR & D Batteries, Inc.
FDA 510(k) clearance K935301 for R & D BATTERIES, INC. PART NUMBERS 5235, 5506 & 5050, Substantially Equivalent on 1994-12-05. Applicant: R & D Batteries, Inc.. Device class: 2.
Clearance details
- Applicant
- R & D Batteries, Inc.
- Product code
- Code HGM
- Device class
- Class 2
- Regulation
- 21 CFR 884.2740
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burnsville, MN, US
Recent devices under product code HGM
view allMore 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 HGM
product code HGM- Death
- 35
- Malfunction
- 478
- Total
- 513
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.