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510(k) K260226

ElintMAX Respiratory Monitor (ElintMAX Monitor A1) by Amptron Medical, Inc. — Product Code BZK

K260226 is an FDA 510(k) premarket notification submitted by Amptron Medical, Inc. for the device "ElintMAX Respiratory Monitor (ElintMAX Monitor A1)". The FDA issued a decision of Substantially Equivalent on September 16, 2026. The device falls under product code BZK (Spirometer, Monitoring (W/Wo Alarm)), a Class II device regulated under 21 CFR 868.1850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2026
Date Received
January 26, 2026
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

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  • 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)
  • K092217 — MERCURY VCO2 (August 21, 2009)

FDA data resources