Clearance Summary
WHISTLE WATCH received FDA 510(k) clearance under submission number K980550, sponsored by Harwill Medical (Pty) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1998-08-27.
- Submission: K980550
- Applicant / Sponsor: Harwill Medical (Pty) , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.1860
- Decision date: 1998-08-27
Classification & Regulation
This clearance is catalogued under FDA product code BZH and 21 CFR 868.1860, within the Anesthesiology review panel as a Class II device.