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FDA 510(k)

AIRWATCH MONITOR

K-Number: K941226 · 1994-11-16

ApplicantEnact Health Management Systems
Decision Date1994-11-16
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRWATCH MONITOR 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 1994-11-16 under 510(k) number K941226. 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 MONITOR?

AIRWATCH MONITOR is a medical device that received FDA 510(k) clearance on 1994-11-16. The listed applicant is Enact Health Management Systems. The 510(k) number is K941226.

When did AIRWATCH MONITOR receive FDA 510(k) clearance?

AIRWATCH MONITOR received FDA 510(k) clearance on 1994-11-16, under 510(k) number K941226.

Who is the listed applicant for AIRWATCH MONITOR?

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 MONITOR?

The FDA product code for AIRWATCH MONITOR 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.

K982675AIRWATCH II ZONELESSK982676AIRWATCH II ZONE

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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