Home / 510(k) Clearances / K896153

510(k) K896153

MODIFIED DR-2C/PMC 100 by General Devices — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1990
Date Received
October 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by General Devices

  • K013533 — EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) (January 18, 2002)
  • K002089 — ROSETTA-LT/ROSETTA-RX (November 21, 2000)
  • K993202 — EIM-107 PREP-CHECK (December 17, 1999)
  • K940009 — GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 (April 14, 1995)
  • K935839 — GEMSCOM SERIES 5000, (November 10, 1994)
  • K921929 — GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) (September 18, 1992)
  • K914889 — GEMSCOM SERIES 3000 (March 4, 1992)
  • K912008 — TRU-VIEW MULTI-CHANNEL DISPLAY (October 9, 1991)
  • K862596 — DR-2C (MODIFICATION) (September 26, 1986)
  • K844650 — DR-2C (January 22, 1985)

Other clearances for product code DSH

  • K253293 — VitaloJAK Clinic (Model 7100) (December 3, 2025)
  • K243650 — Zio® monitor (DFG0001) (August 15, 2025)
  • K243603 — AeviceMD (May 5, 2025)
  • K242583 — AT-Patch (ATP-C130/ATP-C70) (May 2, 2025)
  • K232670 — HiCardi+ H100 (September 20, 2024)
  • K233906 — S-Patch (S-Patch ExL) (February 16, 2024)
  • K231104 — ABPMpro (November 27, 2023)
  • K233110 — Carnation Ambulatory Monitor (November 22, 2023)
  • K230184 — Holter ECG and ABP System (September 25, 2023)
  • K231289 — S-Patch Ex Wearable ECG Patch (August 30, 2023)