The following data is part of a premarket notification filed by Iob Medical Inc with the FDA for Iob Warming Blankets.
| Device ID | K190221 |
| 510k Number | K190221 |
| Device Name: | IOB Warming Blankets |
| Classification | System, Thermal Regulating |
| Applicant | IOB Medical Inc 504E Diamond Ave., Suite I Gaithersburg, MD 20877 |
| Contact | Jiulin Xia |
| Correspondent | Joe Shia LSI International Inc 504E Diamond Ave., Suite J Gaithersburg, MD 20877 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-05 |
| Decision Date | 2019-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18973920006973 | K190221 | 000 |
| 00850035767252 | K190221 | 000 |
| 00850035767900 | K190221 | 000 |
| 20850035767898 | K190221 | 000 |
| 20850035767881 | K190221 | 000 |
| 20850035767874 | K190221 | 000 |
| 20850035767805 | K190221 | 000 |
| 20850035767799 | K190221 | 000 |
| 20850035767782 | K190221 | 000 |
| 20850035767775 | K190221 | 000 |
| 20850035767768 | K190221 | 000 |
| 20850035767751 | K190221 | 000 |
| 20850035767287 | K190221 | 000 |
| 20850035767294 | K190221 | 000 |
| 18973920006966 | K190221 | 000 |
| 18973920006959 | K190221 | 000 |
| 18973920006942 | K190221 | 000 |
| 18973920006935 | K190221 | 000 |
| 08973920006679 | K190221 | 000 |
| 18973920006911 | K190221 | 000 |
| 20850035767997 | K190221 | 000 |
| 20850035767980 | K190221 | 000 |
| 20850035767973 | K190221 | 000 |
| 20850035767966 | K190221 | 000 |
| 20850035767300 | K190221 | 000 |
| 20850035767744 | K190221 | 000 |