510(k) K980550
K980550 is an FDA 510(k) premarket notification submitted by Harwill Medical (Pty) , Ltd. for the device "WHISTLE WATCH". The FDA issued a decision of Substantially Equivalent on August 27, 1998. The device falls under product code BZH (Meter, Peak Flow, Spirometry), a Class II device regulated under 21 CFR 868.1860. Harwill Medical (Pty) , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 1998
- Date Received
- February 12, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Meter, Peak Flow, Spirometry
- Device Class
- Class II
- Regulation Number
- 868.1860
- Review Panel
- AN
- Submission Type