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510(k) K780297

CARDIAC MINISCOPE & MINIGRAPH by Arco Medical Products Co. — Product Code DRT

K780297 is an FDA 510(k) premarket notification submitted by Arco Medical Products Co. for the device "CARDIAC MINISCOPE & MINIGRAPH". The FDA issued a decision of Substantially Equivalent on May 19, 1978. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Arco Medical Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1978
Date Received
February 21, 1978
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 Arco Medical Products Co.

  • K802588 — MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. (November 19, 1980)
  • K801806 — EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE (September 9, 1980)
  • K800837 — PROGRAMMABLE BIPOLAR CARDIAC GENERATOR (June 30, 1980)
  • K801241 — UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. (June 30, 1980)
  • K800838 — ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. (June 4, 1980)
  • K800326 — ARCOLITH 3021-CARDIAC PULSE GENERATOR (March 17, 1980)
  • K792299 — ARCOLITH 3020-CARDIAC PULSE GENERATOR (November 29, 1979)
  • K792216 — ARCOLITH 2100-CARDIAC PULSE GENERATOR (November 29, 1979)
  • K791715 — ARCOLITH 2000 (September 27, 1979)
  • K791147 — ARCO PROGAMMABLE PACEMAKER SYSTEM (August 3, 1979)

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