Home / 510(k) Clearances / K012540

510(k) K012540

BLY-501 ADAPTOR by Micromedical Industries, Ltd. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2001
Date Received
August 7, 2001
Clearance Type
Special
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 Micromedical Industries, Ltd.

  • K013311 — MODIFICATION TO: POCKETVIEW ECG SOFTWARE (January 3, 2002)
  • 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 DPS

  • K251670 — MAC 7 Resting ECG Analysis System (January 26, 2026)
  • 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)