Home / 510(k) Clearances / K904355

510(k) K904355

CARDIOCAP II TM CH-RESP MONITORS by Instrumentarium Corp. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1991
Date Received
September 24, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
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 DPS

  • K251670 — MAC 7 Resting ECG Analysis System (January 26, 2026)
  • K252361 — AccurECG Analysis System (v2.0) (December 22, 2025)
  • K252474 — Withings BeamO (SCT02) (November 10, 2025)
  • K250569 — Cardiologs Holter Platform (August 6, 2025)
  • K243252 — ZBPro Diagnostic (July 10, 2025)
  • K243305 — Masimo W1 (April 3, 2025)
  • K241217 — CloudHRV™ System (100-01-001) (January 16, 2025)
  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
  • K240229 — Masimo W1 (August 8, 2024)
  • K232161 — DeepRhythm Platform (June 20, 2024)