POWERNEB
Device, Positive Pressure Breathing, Intermittent
COMEDICA , INC.
The following data is part of a premarket notification filed by Comedica , Inc. with the FDA for Powerneb.
Pre-market Notification Details
| Device ID | K051964 |
| 510k Number | K051964 |
| Device Name: | POWERNEB |
| Classification | Device, Positive Pressure Breathing, Intermittent |
| Applicant | COMEDICA , INC. 2300 MCDERMOTT ROAD SUITE 200-207 Plano, TX 75025 |
| Contact | Krista Oakes |
| Correspondent | Krista Oakes COMEDICA , INC. 2300 MCDERMOTT ROAD SUITE 200-207 Plano, TX 75025 |
| Product Code | NHJ |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-20 |
| Decision Date | 2005-12-01 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887761997158 | K051964 | 000 |
Trademark Results [POWERNEB]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POWERNEB 78344143 2963223 Dead/Cancelled |
COMEDICA INCORPORATED 2003-12-22 |
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