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 |