Home / 510(k) Clearances / K013311

510(k) K013311

MODIFICATION TO: POCKETVIEW ECG SOFTWARE by Micromedical Industries, Ltd. — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2002
Date Received
October 4, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Micromedical Industries, Ltd.

  • K012540 — BLY-501 ADAPTOR (September 26, 2001)
  • K990266 — MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE (February 2, 1999)
  • K922528 — CMS SYSTEM (May 12, 1995)
  • K915624 — MODIFIED BIOLOG (March 27, 1992)
  • K915627 — PACEVIEW (March 27, 1992)

Other clearances for product code MHX

  • K252726 — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX10 (February 6, 2026)
  • K252589 — Corvair Monza (January 9, 2026)
  • K250854 — Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); (December 17, 2025)
  • K251702 — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4 (November 10, 2025)
  • K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550 (October 17, 2025)
  • K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); (September 2, 2025)
  • K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (July 29, 2025)
  • K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (July 9, 2025)
  • K250757 — Radius VSM and Accessories (May 29, 2025)
  • K242962 — Telemetry Monitor 5500 Release 4.0 (867232) (May 5, 2025)