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FDA 510(k)

AIRWATCH II ZONELESS

K-Number: K982675 · 1998-10-29

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

Device Summary

AIRWATCH II ZONELESS 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 K982675. 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 ZONELESS?

AIRWATCH II ZONELESS 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 K982675.

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

AIRWATCH II ZONELESS received FDA 510(k) clearance on 1998-10-29, under 510(k) number K982675.

Who is the listed applicant for AIRWATCH II ZONELESS?

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 ZONELESS?

The FDA product code for AIRWATCH II ZONELESS 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.

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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.

K982676AIRWATCH II ZONEK941226AIRWATCH 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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