Home / 510(k) Clearances / K864261

510(k) K864261

MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR by Bio-Dyne, Inc. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1987
Date Received
October 29, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Bio-Dyne, Inc.

  • K900691 — BIODYNE INSTRUMENT WIPES (March 8, 1990)
  • K883984 — HEMORX COLD PACK (December 22, 1988)

Other clearances for product code BZQ

  • K250093 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (September 26, 2025)
  • K250934 — Respiree Cardio- Respiratory Monitor System (August 5, 2025)
  • K243183 — RTMsense Respiratory Monitoring System (June 27, 2025)
  • K243966 — FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (April 9, 2025)
  • K242001 — Philips VSC-MEDlib (April 4, 2025)
  • K233953 — Makani Science™ Respiration Monitoring System (March 28, 2025)
  • K242798 — Airmod (February 28, 2025)
  • K240271 — Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (September 11, 2024)
  • K223681 — Respiree Cardio-Respiratory Monitor (March 8, 2023)
  • K221555 — Dozee VS (December 15, 2022)