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510(k) K892006

HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S by Healthdyne, Inc. — Product Code DRT

K892006 is an FDA 510(k) premarket notification submitted by Healthdyne, Inc. for the device "HEALTHDYNE'S APNEA/HEART MONITOR, MODEL 900S". The FDA issued a decision of Substantially Equivalent on May 23, 1989. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Healthdyne, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1989
Date Received
March 28, 1989
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 Healthdyne, Inc.

  • K950331 — PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) (September 21, 1995)
  • K922106 — ALICE (July 6, 1994)
  • K942357 — H-500 ALLIANCE OXYGEN CONCENTRATOR (May 27, 1994)
  • K934502 — FLOW SPIROMETER (April 4, 1994)
  • K924146 — OH-500 OXYGEN CONCENTRATOR (January 7, 1993)
  • K922623 — NEBULIZER SYSTEM (December 1, 1992)
  • K910118 — DATA RECORDER (February 14, 1991)
  • K903287 — MODEL 900S APNEA/HEART MONITOR (August 17, 1990)
  • K894030 — MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR (January 22, 1990)
  • K890150 — H-3000 OXYGEN CONCENTRATOR (January 31, 1989)

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