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FDA 510(k)

AIRWATCH II ZONE

K-Number: K982676 · 1998-10-29

ApplicantEnact Health Management Systems
Decision Date1998-10-29
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRWATCH II ZONE is the device name listed in this FDA 510(k) record. The listed applicant is Enact Health Management Systems. It received FDA 510(k) clearance on 1998-10-29 under 510(k) number K982676. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIRWATCH II ZONE?

AIRWATCH II ZONE is a medical device that received FDA 510(k) clearance on 1998-10-29. The listed applicant is Enact Health Management Systems. The 510(k) number is K982676.

When did AIRWATCH II ZONE receive FDA 510(k) clearance?

AIRWATCH II ZONE received FDA 510(k) clearance on 1998-10-29, under 510(k) number K982676.

Who is the listed applicant for AIRWATCH II ZONE?

The FDA 510(k) record lists Enact Health Management Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AIRWATCH II ZONE?

The FDA product code for AIRWATCH II ZONE is BZH.

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 Enact Health Management Systems 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.

K982675AIRWATCH II ZONELESSK941226AIRWATCH MONITOR

Related Devices (Code: BZH)

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.

K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife CorporationK252802Peak Flow Meter (PF-10(BR-PEF231))Shenzhen Bi-Rich Medical Devices Co., Ltd.K241338Peak Flow MeterChongqing Moffy Innovation Technology Co., Ltd.K232588Aluna 2Knox Medical DiagnosticsK230423Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd.K222810TD-7301 Peak Flow meterGostar Co., Ltd.

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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