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510(k) K042002

SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER by Ela Medical, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2004
Date Received
July 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

Other clearances by Ela Medical, Inc.

  • K032466 — SPIDERVIEW (August 22, 2003)
  • K002817 — SYNETEC (May 2, 2001)
  • K993448 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHA (April 10, 2000)
  • K000029 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHA (April 4, 2000)
  • K990727 — SYNEFLASH & SYNEVIEW (November 26, 1999)
  • K972574 — STELA MODEL UJ45 PACING LEADS (January 8, 1998)
  • K970072 — OPUS S MODEL 4121 AND 4124 PACEMAKERS (August 29, 1997)
  • K963738 — STELA MODEL BJ44 AND BJ45 PACING LEADS (May 23, 1997)
  • K952364 — OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) (September 1, 1995)
  • K952363 — OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034) (August 15, 1995)

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  • K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) (December 18, 2025)
  • K253141 — DeepRhythmAI (December 11, 2025)