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510(k) K850114

C/PES 9201, ECG STRESS TESTING SYS by Gould, Inc. — Product Code DRT

K850114 is an FDA 510(k) premarket notification submitted by Gould, Inc. for the device "C/PES 9201, ECG STRESS TESTING SYS". The FDA issued a decision of Substantially Equivalent on February 22, 1985. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Gould, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1985
Date Received
January 14, 1985
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 Gould, Inc.

  • K911935 — CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED (July 22, 1991)
  • K861092 — MODEL SP1465 CARDIAC OUTPUT COMPUTER (August 18, 1986)
  • K860805 — PRESSURE MONITOR CATH MODELS SP5325,SP5327,SP5337 (May 8, 1986)
  • K855145 — MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR (February 26, 1986)
  • K854403 — MODEL 2120 SPIROSCREEN (January 14, 1986)
  • K851486 — GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX (October 17, 1985)
  • K850113 — C/PES 9103, ECG STRESS TESTING SYSTEM (February 8, 1985)
  • K843555 — CARDIAC COMPUTER SP1445 (February 1, 1985)
  • K843969 — MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER (January 23, 1985)
  • K843970 — MODEL IM1074 END-TIDAL CO2 MODULE (October 24, 1984)

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