NCE REPLACEMENT BATTERIES— 510(k) K941995
Substantially Equivalent - Subject to Tracking Reg.National Custom Ent., Inc.
FDA 510(k) clearance K941995 for NCE REPLACEMENT BATTERIES, Substantially Equivalent - Subject to Tracking Reg. on 1994-07-26. Applicant: National Custom Ent., Inc.. Device class: 2.
Clearance details
- Applicant
- National Custom Ent., Inc.
- Product code
- Code LDD
- Device class
- Class 2
- Regulation
- 21 CFR 870.5300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Burnsville, MN, US
Recent devices under product code LDD
view allMore clearances from National Custom Ent., Inc.
view all- K012263 — MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024
- K012264 — MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC
- K012259 — MEDFUSION 2001 & 2010, MODEL N7215IWC
- K012262 — BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC
- K012266 — SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
Adverse events under product code LDD
product code LDD- Death
- 38
- Malfunction
- 522
- Total
- 560
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.