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510(k) K012264

MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC by National Custom Ent., Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2001
Date Received
July 18, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by National Custom Ent., Inc.

  • K012263 — MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 (October 10, 2001)
  • K012266 — SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 (September 12, 2001)
  • K012259 — MEDFUSION 2001 & 2010, MODEL N7215IWC (September 12, 2001)
  • K012262 — BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC (September 12, 2001)
  • K012229 — SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C (September 10, 2001)
  • K943680 — NCE REPLACEMENT BATTERIES (November 4, 1994)
  • K943632 — REPLACEMENT BATTERIES (November 4, 1994)
  • K942629 — NCE REPLACEMENT BATTERIES (August 18, 1994)
  • K941995 — NCE REPLACEMENT BATTERIES (July 26, 1994)
  • K942244 — REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE (June 24, 1994)

Other clearances for product code DPS

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  • K252361 — AccurECG Analysis System (v2.0) (December 22, 2025)
  • K252474 — Withings BeamO (SCT02) (November 10, 2025)
  • K250569 — Cardiologs Holter Platform (August 6, 2025)
  • K243252 — ZBPro Diagnostic (July 10, 2025)
  • K243305 — Masimo W1 (April 3, 2025)
  • K241217 — CloudHRV™ System (100-01-001) (January 16, 2025)
  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
  • K240229 — Masimo W1 (August 8, 2024)
  • K232161 — DeepRhythm Platform (June 20, 2024)