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FDA 510(k)

BREATH TRACKER

K-Number: K892942 · 1989-06-23

ApplicantCore-M, Inc.
Decision Date1989-06-23
Product CodeCAP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREATH TRACKER is the device name listed in this FDA 510(k) record. The listed applicant is Core-M, Inc.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K892942. The device is classified under product code CAP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATH TRACKER?

BREATH TRACKER is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Core-M, Inc.. The 510(k) number is K892942.

When did BREATH TRACKER receive FDA 510(k) clearance?

BREATH TRACKER received FDA 510(k) clearance on 1989-06-23, under 510(k) number K892942.

Who is the listed applicant for BREATH TRACKER?

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

What is the FDA product code for BREATH TRACKER?

The FDA product code for BREATH TRACKER is CAP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Core-M, Inc. as applicant

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.

K960861OMICRON MONITOR, DELTA MONITORK921978BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE

Related Devices (Code: CAP)

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.

K201666SINGLE USE MANOMETERFlexicare Medical Limited.K182292VORTRAN APM-PlusVortran Medical Technology 1, Inc.K180510NS 120P-TRS Airway Pressure GaugeInstrumentation Industries, Inc.K172284NAPA LP-15 Airway Pressure MonitorDrw Medical, LLCK153733VORTRAN ManometerVortran Medical Technology 1, Inc.K122627GIO DIGITAL PRESSURE GUAGESGalemed Corp.

Official Source

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

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