Home / 510(k) Clearances / K915624

510(k) K915624

MODIFIED BIOLOG by Micromedical Industries, Ltd. — Product Code DRT

K915624 is an FDA 510(k) premarket notification submitted by Micromedical Industries, Ltd. for the device "MODIFIED BIOLOG". The FDA issued a decision of Substantially Equivalent on March 27, 1992. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Micromedical Industries, Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1992
Date Received
December 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Micromedical Industries, Ltd.

  • K013311 — MODIFICATION TO: POCKETVIEW ECG SOFTWARE (January 3, 2002)
  • K012540 — BLY-501 ADAPTOR (September 26, 2001)
  • K990266 — MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE (February 2, 1999)
  • K922528 — CMS SYSTEM (May 12, 1995)
  • K915627 — PACEVIEW (March 27, 1992)

Other clearances for product code DRT

  • K261286 — The Circadia C300 System (C300) (May 20, 2026)
  • K252676 — The Circadia C300 System (C300) (February 3, 2026)
  • K253388 — Sleepiz One+ (Model 2.5) (January 28, 2026)
  • K251364 — Sleepiz One+ (2.5) (July 29, 2025)
  • K234003 — The Circadia C200 System (May 30, 2024)
  • K232354 — Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central (March 22, 2024)
  • K231733 — Neteera 130H-Plus Vital Sign Monitoring Sensor (February 9, 2024)
  • K223163 — Sleepiz One+ (August 18, 2023)
  • K212143 — Neteera 130H/131H Vital Sign Monitoring Sensor (September 28, 2022)
  • K202138 — Cardiac Trigger Monitor (May 14, 2021)

FDA data resources