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FDA 510(k)

RESPALERT

K-Number: K992618 · 1999-10-29

ApplicantHarwill Medical (Pty) , Ltd.
Decision Date1999-10-29
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

RESPALERT is the device name listed in this FDA 510(k) record. The listed applicant is Harwill Medical (Pty) , Ltd.. It received FDA 510(k) clearance on 1999-10-29 under 510(k) number K992618. 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 RESPALERT?

RESPALERT is a medical device that received FDA 510(k) clearance on 1999-10-29. The listed applicant is Harwill Medical (Pty) , Ltd.. The 510(k) number is K992618.

When did RESPALERT receive FDA 510(k) clearance?

RESPALERT received FDA 510(k) clearance on 1999-10-29, under 510(k) number K992618.

Who is the listed applicant for RESPALERT?

The FDA 510(k) record lists Harwill Medical (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESPALERT?

The FDA product code for RESPALERT is BZH.

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Other records listing Harwill Medical (Pty) , Ltd. 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.

K983202HARWILL MEDICAL CERVITULA CERVICAL SPATULAK983204HARWILL MEDICAL U-KLIP UMBILICAL CLAMPK980550WHISTLE WATCH

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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