NCE REPLACEMENT BATTERIES— 510(k) K942629
Substantially EquivalentNational Custom Ent., Inc.
FDA 510(k) clearance K942629 for NCE REPLACEMENT BATTERIES, Substantially Equivalent on 1994-08-18. Applicant: National Custom Ent., Inc.. Device class: 2.
Clearance details
- Applicant
- National Custom Ent., Inc.
- Product code
- Code DPS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burnsville, MN, US
Recent devices under product code DPS
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 DPS
product code DPS- Death
- 7
- Total
- 7
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.