Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

WHISTLE WATCH

K-Number: K980550 · 1998-08-27

ApplicantHarwill Medical (Pty) , Ltd.
Decision Date1998-08-27
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WHISTLE WATCH 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 1998-08-27 under 510(k) number K980550. 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 WHISTLE WATCH?

WHISTLE WATCH is a medical device that received FDA 510(k) clearance on 1998-08-27. The listed applicant is Harwill Medical (Pty) , Ltd.. The 510(k) number is K980550.

When did WHISTLE WATCH receive FDA 510(k) clearance?

WHISTLE WATCH received FDA 510(k) clearance on 1998-08-27, under 510(k) number K980550.

Who is the listed applicant for WHISTLE WATCH?

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 WHISTLE WATCH?

The FDA product code for WHISTLE WATCH 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 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.

K992618RESPALERTK983202HARWILL MEDICAL CERVITULA CERVICAL SPATULAK983204HARWILL MEDICAL U-KLIP UMBILICAL CLAMP

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.

↑