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510(k) K853953

CARDIOCAP MONITOR by Instrumentarium Corp. — Product Code DRT

K853953 is an FDA 510(k) premarket notification submitted by Instrumentarium Corp. for the device "CARDIOCAP MONITOR". The FDA issued a decision of Substantially Equivalent on June 2, 1986. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Instrumentarium Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1986
Date Received
September 25, 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 Instrumentarium Corp.

  • K022630 — MODIFICATION TO FOCUS (October 9, 2002)
  • K001729 — FOCUS (July 13, 2000)
  • K001439 — ORTHOCEPH OC100 D (June 22, 2000)
  • K992385 — ORTHOPANTOMOGRAPH OP100D (September 28, 1999)
  • K981641 — MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA (July 17, 1998)
  • K962638 — TONOCAP, TC-200 AND ACCESSORY CATHETERS (April 4, 1997)
  • K961441 — TONOMETERED SLAINE BLOOD GAS CONTROL (April 30, 1996)
  • K955018 — TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATOR (January 30, 1996)
  • K934478 — ALPHA STEREO (January 31, 1995)
  • K923433 — AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE (July 22, 1993)

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