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FDA 510(k)

BREATHSCN PRO

K-Number: K102338 · 2011-01-12

ApplicantAkers Biosciences, Inc.
Decision Date2011-01-12
Product CodeDJZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BREATHSCN PRO is the device name listed in this FDA 510(k) record. The listed applicant is Akers Biosciences, Inc.. It received FDA 510(k) clearance on 2011-01-12 under 510(k) number K102338. The device is classified under product code DJZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREATHSCN PRO?

BREATHSCN PRO is a medical device that received FDA 510(k) clearance on 2011-01-12. The listed applicant is Akers Biosciences, Inc.. The 510(k) number is K102338.

When did BREATHSCN PRO receive FDA 510(k) clearance?

BREATHSCN PRO received FDA 510(k) clearance on 2011-01-12, under 510(k) number K102338.

Who is the listed applicant for BREATHSCN PRO?

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

What is the FDA product code for BREATHSCN PRO?

The FDA product code for BREATHSCN PRO is DJZ.

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 Akers Biosciences, 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.

K062971BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMSK060761BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORSK052697HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANELK050338MODIFICATION TO: INSTAREAD LITHIUM SYSTEM

Related Devices (Code: DJZ)

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.

K160613Soberlink Cellular Device and Sober Sky Web PortalSoberlink Healthcare, LLCK123470PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITEPas Systems International, Inc.K110614PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEMSeju Engineering Co., Ltd.K102225ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TESTAlcopro, Inc.K100879CONTRALCOContralcoK093143MISSION BREATH ALCOHOL DETECTORACON Laboratories, 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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