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510(k) K790004

MONITOR SCOPES, MODELS 9502, 9503 by C-V Monitors Corp. — Product Code DRT

K790004 is an FDA 510(k) premarket notification submitted by C-V Monitors Corp. for the device "MONITOR SCOPES, MODELS 9502, 9503". The FDA issued a decision of Substantially Equivalent on February 28, 1979. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. C-V Monitors Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1979
Date Received
January 2, 1979
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 C-V Monitors Corp.

  • K792099 — 50MM WRITER MODEL CVM 9529 (October 26, 1979)
  • K781867 — WRITER, GEMINI-3 (January 5, 1979)
  • K780572 — DCG PREAMPLIFIER MODULE (May 9, 1978)
  • K780571 — BLOOD PRESSURE MODULE (May 9, 1978)

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