The following data is part of a premarket notification filed by Watermark Medical with the FDA for Mipal.
| Device ID | K120470 |
| 510k Number | K120470 |
| Device Name: | MIPAL |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | WATERMARK MEDICAL 12715 FALCON DRIVE Brookfield, WI 53005 |
| Contact | Michael J Leigh |
| Correspondent | Michael J Leigh WATERMARK MEDICAL 12715 FALCON DRIVE Brookfield, WI 53005 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-16 |
| Decision Date | 2012-06-08 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MIPAL 88136034 not registered Live/Pending |
Watermark Medical, Inc. 2018-09-28 |
![]() MIPAL 86643387 not registered Dead/Abandoned |
Clausen, Alvin Frederick, 2015-05-28 |
![]() MIPAL 85390291 not registered Dead/Abandoned |
Watermark Medical, LLC 2011-08-05 |
![]() MIPAL 78639436 not registered Dead/Abandoned |
Starkey Laboratories, Inc. 2005-05-27 |