VISIONAIR
Rhinoanemometer (measurement Of Nasal Decongestion)
PacificMD Biotech Llc
The following data is part of a premarket notification filed by Pacificmd Biotech Llc with the FDA for Visionair.
Pre-market Notification Details
| Device ID | K221892 |
| 510k Number | K221892 |
| Device Name: | VISIONAIR |
| Classification | Rhinoanemometer (measurement Of Nasal Decongestion) |
| Applicant | PacificMD Biotech Llc 3195 Saint Rose Pkwy, Suite 210 Henderson, NV 89052 |
| Contact | Jetmir Palushi |
| Correspondent | David M. Locke Canyon Labs 6217 South Bringhurst Blvd, Suite 600 Bluffdale, UT 84065 |
| Product Code | BXQ |
| CFR Regulation Number | 868.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-29 |
| Decision Date | 2022-10-05 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860009626805 | K221892 | 000 |
Trademark Results [VISIONAIR]
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