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510(k) K935817

MEDSIM 300 PATIENT SIMULATOR by Dynatech/Nevada, Inc. — Product Code DRT

K935817 is an FDA 510(k) premarket notification submitted by Dynatech/Nevada, Inc. for the device "MEDSIM 300 PATIENT SIMULATOR". The FDA issued a decision of Substantially Equivalent on January 18, 1994. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Dynatech/Nevada, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1994
Date Received
December 2, 1993
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 Dynatech/Nevada, Inc.

  • K942546 — CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER (January 27, 1995)
  • K934254 — IMPULSE 3000 DEFIBRILLATOR ANALYZER (November 23, 1993)
  • K897074 — MODEL 215M PATIENT SIMULATOR (May 17, 1990)
  • K897029 — MODEL ECG100 SIMULATOR (April 26, 1990)
  • K897096 — MODEL 404A I.V. INFUSION PUMP ANALYZER (March 15, 1990)

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