RESPALERT
Meter, Peak Flow, Spirometry
HARWILL MEDICAL (PTY) LTD.
The following data is part of a premarket notification filed by Harwill Medical (pty) Ltd. with the FDA for Respalert.
Pre-market Notification Details
| Device ID | K992618 |
| 510k Number | K992618 |
| Device Name: | RESPALERT |
| 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 | 1999-08-04 |
| Decision Date | 1999-10-29 |
Trademark Results [RESPALERT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RESPALERT 75603025 not registered Dead/Abandoned |
HARWILL INDUSTRIES (PTY) LTD. 1998-12-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.