The following data is part of a premarket notification filed by Innonix Technologies Limited with the FDA for Innonix Antiviral Child's Face Mask.
| Device ID | K192105 |
| 510k Number | K192105 |
| Device Name: | Innonix Antiviral Child's Face Mask |
| Classification | Surgical Mask With Antimicrobial/antiviral Agent |
| Applicant | Innonix Technologies Limited 13/F LiFung Centre, 2 On Ping Street Siu Lek Yuen,shatin, HK |
| Contact | Tommy Lui |
| Correspondent | Reid Von Borsel Innonix Technologies Limited 10017 Sorrel Ave Potomac, MD 20854 |
| Product Code | OUK |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-05 |
| Decision Date | 2019-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840039200640 | K192105 | 000 |