Marquette Eagle Monitor Model 4000, Model N3024
FDA 510(k) K012263 · National Custom Ent., Inc.
510(k) numberK012263
Submission
- Device name
- Marquette Eagle Monitor Model 4000, Model N3024
- Applicant
- National Custom Ent., Inc.
Burnsville, MN, US - Received
- July 18, 2001
- Decision date
- October 10, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DPS – Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2340
- Specialty
- Cardiovascular
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|---|---|---|---|
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | Edan Instruments, Inc. | 07/02/2026SE |
| K251670 | MAC 7 Resting ECG Analysis SystemDPS · Traditional | Ge Medical Systems Information Technologies, Inc. | 01/26/2026SE |
| K252361 | AccurECG Analysis System (v2.0)DPS · Traditional | Accurkardia, Inc. | 12/22/2025SE |
| K252474 | Withings BeamO (SCT02)DPS · Traditional | Withings | 11/10/2025SE |
| K250569 | Cardiologs Holter PlatformDPS · Traditional | Philips France Commercial | 08/06/2025SE |
| K243252 | ZBPro DiagnosticDPS · Traditional | Zbeats, Inc. | 07/10/2025SE |
| K243305 | Masimo W1DPS · Traditional | Masimo Corporation | 04/03/2025SE |
| K241217 | CloudHRV System (100-01-001)DPS · Traditional | Inmedix, Inc. | 01/16/2025SE |
| K241556 | Cardiac Workstation (5000); Cardiac Workstation (7000)DPS · Traditional | Philips Medizin Systeme Böblingen GmbH | 12/17/2024SE |
| K240229 | Masimo W1DPS · Traditional | Masimo Corporation | 08/08/2024SE |
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| K012264 | Marquette MAC8, Mac Personal, Mac Stress, Model N3043IWCDPS · Traditional | 10/10/2001SE |
| K012266 | Sherwood 224, 324 Feeding Pump & K524 Intri-Flush, Model N7213IWC2MRZ · Traditional | 09/12/2001SE |
| K012262 | Baxter AS40A, AS41 Syringe Pump, Model N61WCMRZ · Traditional | 09/12/2001SE |
| K012259 | Medfusion 2001 & 2010, Model N7215IWCMRZ · Traditional | 09/12/2001SE |
| K012229 | Scale-Tronix 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C &…FMT · Traditional | 09/10/2001SE |
| K943680 | Nce Replacement BatteriesFCO · Traditional | 11/04/1994SE |
| K943632 | Replacement BatteriesFCO · Traditional | 11/04/1994SE |
| K942629 | Nce Replacement BatteriesDPS · Traditional | 08/18/1994SE |
| K941995 | Nce Replacement BatteriesLDD · Traditional | 07/26/1994ST |
| K942244 | Replacement Batteries/Welch Allyn #72200 Power HandleERA · Traditional | 06/24/1994SE |
Questions and answers
When was Marquette Eagle Monitor Model 4000, Model N3024 cleared by the FDA?
Marquette Eagle Monitor Model 4000, Model N3024 (K012263) received a 510(k) decision of Substantially Equivalent on October 10, 2001, 84 days after the submission was received.
What is the product code of K012263?
The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.