MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC— 510(k) K012264
Substantially EquivalentNational Custom Ent., Inc.
FDA 510(k) clearance K012264 for MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC, Substantially Equivalent on 2001-10-10. 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
- 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
- K012229 — SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC
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.