SUITEHEART
System, Image Processing, Radiological
NEOSOFT, LLC
The following data is part of a premarket notification filed by Neosoft, Llc with the FDA for Suiteheart.
Pre-market Notification Details
| Device ID | K130228 |
| 510k Number | K130228 |
| Device Name: | SUITEHEART |
| Classification | System, Image Processing, Radiological |
| Applicant | NEOSOFT, LLC N27 W23910A PAUL RD. Pewaukee, WI 53186 |
| Contact | Jackie Schwabe |
| Correspondent | Jackie Schwabe NEOSOFT, LLC N27 W23910A PAUL RD. Pewaukee, WI 53186 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-29 |
| Decision Date | 2013-03-20 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864747000279 | K130228 | 000 |
| 00864747000262 | K130228 | 000 |
| 00864747000255 | K130228 | 000 |
| 00864747000248 | K130228 | 000 |
| 00864747000224 | K130228 | 000 |
| 00864747000217 | K130228 | 000 |
| 00864747000200 | K130228 | 000 |
| 00850001088008 | K130228 | 000 |
| 00850001088015 | K130228 | 000 |
Trademark Results [SUITEHEART]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUITEHEART 85821792 4685236 Live/Registered |
NEOSOFT, LLC. 2013-01-11 |
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