National Custom Ent., Inc.
Burnsville, MN, US
National Custom Ent., Inc. appears in FDA device records in Burnsville, MN. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for National Custom Ent., Inc. between 1993 and 2001. The busiest year on record is 2001, with 6. The most recent is 2001, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1994 | 5 |
| 2001 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K012264 | MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC | DPS | Substantially Equivalent | |
| K012263 | MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 | DPS | Substantially Equivalent | |
| K012266 | SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 | MRZ | Substantially Equivalent | |
| K012262 | BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC | MRZ | Substantially Equivalent | |
| K012259 | MEDFUSION 2001 & 2010, MODEL N7215IWC | MRZ | Substantially Equivalent | |
| K012229 | SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC | FMT | Substantially Equivalent | |
| K943680 | NCE REPLACEMENT BATTERIES | FCO | Substantially Equivalent | |
| K943632 | REPLACEMENT BATTERIES | FCO | Substantially Equivalent | |
| K942629 | NCE REPLACEMENT BATTERIES | DPS | Substantially Equivalent | |
| K941995 | NCE REPLACEMENT BATTERIES | LDD | Substantially Equivalent - Subject to Tracking Reg. | |
| K942244 | REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE | ERA | Substantially Equivalent | |
| K934067 | POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 | DRK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain