Plasma IQ
Electrosurgical, Cutting & Coagulation & Accessories
Neauvia North America, Inc
The following data is part of a premarket notification filed by Neauvia North America, Inc with the FDA for Plasma Iq.
Pre-market Notification Details
| Device ID | K192813 |
| 510k Number | K192813 |
| Device Name: | Plasma IQ |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Neauvia North America, Inc 8480 Honeycutt Rd Raleigh, NC 27615 |
| Contact | Misty Williams |
| Correspondent | Misty Williams Neauvia North America, Inc 8480 Honeycutt Rd Raleigh, NC 27615 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-01 |
| Decision Date | 2020-03-06 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850017374119 | K192813 | 000 |
| 00850017374102 | K192813 | 000 |
| 00850017374041 | K192813 | 000 |
| 00850017374034 | K192813 | 000 |
| 00850017374027 | K192813 | 000 |
| 00850017374010 | K192813 | 000 |
| 00850017374003 | K192813 | 000 |
Trademark Results [Plasma IQ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLASMA IQ 79297164 not registered Live/Pending |
BERGER & KRAFT MEDICAL Sp. z o. o. 2020-09-18 |
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