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FDA 510(k)

ElintMAX Respiratory Monitor (ElintMAX Monitor A1)

K-Number: K260226 · 2026-09-16

ApplicantAmptron Medical, Inc.
Decision Date2026-09-16
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ElintMAX Respiratory Monitor (ElintMAX Monitor A1) is the device name listed in this FDA 510(k) record. The listed applicant is Amptron Medical, Inc.. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K260226. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ElintMAX Respiratory Monitor (ElintMAX Monitor A1)?

ElintMAX Respiratory Monitor (ElintMAX Monitor A1) is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is Amptron Medical, Inc.. The 510(k) number is K260226.

When did ElintMAX Respiratory Monitor (ElintMAX Monitor A1) receive FDA 510(k) clearance?

ElintMAX Respiratory Monitor (ElintMAX Monitor A1) received FDA 510(k) clearance on 2026-09-16, under 510(k) number K260226.

Who is the listed applicant for ElintMAX Respiratory Monitor (ElintMAX Monitor A1)?

The FDA 510(k) record lists Amptron Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ElintMAX Respiratory Monitor (ElintMAX Monitor A1)?

The FDA product code for ElintMAX Respiratory Monitor (ElintMAX Monitor A1) is BZK.

Related Devices (Code: BZK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192584BEACON Caresystem Model 00002144Mermaid Care A/SK192595ExSpiron 2XiRespiratory MotionK180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K173181ExSpiron 1XiRespiratory Motion, Inc.K162131ExSpiron 1XiRespiratory Motion, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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