Home / 510(k) Clearances / K874326

510(k) K874326

SYSTEM VI MONITOR by Air-Shields, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1988
Date Received
October 21, 1987
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 Air-Shields, Inc.

  • K974248 — WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM (October 7, 1998)
  • K972309 — JM-102 JAUNDICE METER (September 22, 1998)
  • K971256 — DUO-LITE PHOTOTHERAPY SYSTEM (September 24, 1997)
  • K960980 — ISOLETTE INFANT INCUBATOR (July 30, 1996)
  • K924709 — SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE (January 17, 1996)
  • K940951 — RW RESUCITAIRE INFANT RADIANT WARMER (May 3, 1995)
  • K940975 — C450/C400 INFANT INCUBATORS (June 23, 1994)
  • K941106 — MODEL TI500 ISOLETTE INFANT INCUBATOR (June 10, 1994)
  • K924170 — ISOLETTE INCUBATOR HUMIDITY METER (February 5, 1993)
  • K922150 — EXAMINATION LAMP (July 21, 1992)

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)