Home / 510(k) Clearances / K903331

510(k) K903331

ROZINN 151 by Rozinn Electronics, Inc. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1990
Date Received
July 25, 1990
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 Rozinn Electronics, Inc.

  • K061780 — TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS + (September 15, 2006)
  • K042463 — HOLTER PLUS (September 22, 2004)
  • K022540 — CARDIO ID+(RZ153+) (October 24, 2002)
  • K021517 — ABP FOR WINDOWS (July 24, 2002)
  • K020213 — NETLINK/NETSCAN (April 5, 2002)

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)