MODEL 900S APNEA/HEART MONITOR— 510(k) K903287

Name: FDA 510(k) clearance K903287
Creator: U.S. Food and Drug Administration
Published: 1990-08-17

Substantially Equivalent

Healthdyne, Inc.

FDA 510(k) clearance K903287 for MODEL 900S APNEA/HEART MONITOR, Substantially Equivalent on 1990-08-17. Applicant: Healthdyne, Inc.. Device class: 2.

Clearance details

Applicant: Healthdyne, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1990-07-11
Decision date: 1990-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZQ

view all

K253274 — BedDot (G1)2026-06-25
K251326 — Respiration Rate algorithm2026-06-11
K250093 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)2025-09-26
K250934 — Respiree Cardio- Respiratory Monitor System2025-08-05
K243183 — RTMsense Respiratory Monitoring System2025-06-27

More clearances from Healthdyne, Inc.

view all

K950331 — PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)1995-09-21
K922106 — ALICE1994-07-06
K942357 — H-500 ALLIANCE OXYGEN CONCENTRATOR1994-05-27
K934502 — FLOW SPIROMETER1994-04-04
K924146 — OH-500 OXYGEN CONCENTRATOR1993-01-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.