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510(k) K884959

RESPITRAK by Non-Invasive Monitoring Systems, Inc. — Product Code BZK

K884959 is an FDA 510(k) premarket notification submitted by Non-Invasive Monitoring Systems, Inc. for the device "RESPITRAK". The FDA issued a decision of Substantially Equivalent on June 8, 1989. The device falls under product code BZK (Spirometer, Monitoring (W/Wo Alarm)), a Class II device regulated under 21 CFR 868.1850. Non-Invasive Monitoring Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1989
Date Received
November 29, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
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)
  • K903011 — RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL (March 29, 1991)

Other clearances for product code BZK

  • K260226 — ElintMAX Respiratory Monitor (ElintMAX Monitor A1) (September 16, 2026)
  • K192584 — BEACON Caresystem Model 00002144 (December 18, 2019)
  • K192595 — ExSpiron 2Xi (December 17, 2019)
  • K180788 — Gas Module 3 (October 24, 2018)
  • K173181 — ExSpiron 1Xi (March 16, 2018)
  • K162131 — ExSpiron 1Xi (May 9, 2017)
  • K130170 — EXSPIRON 1XI (May 29, 2013)
  • K120087 — EXSPIRON (September 26, 2012)
  • K103578 — PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST (June 2, 2011)
  • K091853 — WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-01 (September 21, 2009)

FDA data resources