ACCUSOM
Ventilatory Effort Recorder
NOVASOM, INC.
The following data is part of a premarket notification filed by Novasom, Inc. with the FDA for Accusom.
Pre-market Notification Details
| Device ID | K110486 |
| 510k Number | K110486 |
| Device Name: | ACCUSOM |
| Classification | Ventilatory Effort Recorder |
| Applicant | NOVASOM, INC. 801 CROMWELL PARK DRIVE Glen Burnie, MD 21061 |
| Contact | Roger K Richardson |
| Correspondent | Roger K Richardson NOVASOM, INC. 801 CROMWELL PARK DRIVE Glen Burnie, MD 21061 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-22 |
| Decision Date | 2011-08-12 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860512000253 | K110486 | 000 |
| 00860512000291 | K110486 | 000 |
| 00860512000277 | K110486 | 000 |
| 00860512000260 | K110486 | 000 |
| 03615220004157 | K110486 | 000 |
| 03615220004140 | K110486 | 000 |
| 03615220004133 | K110486 | 000 |
Trademark Results [ACCUSOM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCUSOM 85118635 4147299 Live/Registered |
NOVASOM, INC. 2010-08-30 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.