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510(k) K903011

RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL by Non-Invasive Monitoring Systems, Inc. — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1991
Date Received
July 9, 1990
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 Non-Invasive Monitoring Systems, Inc.

  • K012020 — RESPIEVENTS SOFTWARE IS EVENT DATA PROCESSING SOFWARE FOR A PC (August 21, 2001)
  • K001369 — RESPIEVENTS, VERSION 4.2 (July 26, 2000)
  • K942771 — RESPIEVENTS (February 13, 1996)
  • K942852 — RESPITRACE PT (February 13, 1996)
  • K884959 — RESPITRAK (June 8, 1989)

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  • 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)