The following data is part of a premarket notification filed by Harwill Medical (pty) Ltd. with the FDA for Whistle Watch.
| Device ID | K980550 |
| 510k Number | K980550 |
| Device Name: | WHISTLE WATCH |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | HARWILL MEDICAL (PTY) LTD. P O BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith HARWILL MEDICAL (PTY) LTD. P O BOX 4341 Crofton, MD 21114 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-12 |
| Decision Date | 1998-08-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() WHISTLE WATCH 75544808 not registered Dead/Abandoned |
Baskind, Les 1998-08-28 |