SLEEPWIZARD
Ventilatory Effort Recorder
NELLCOR PURITAN BENNETT, INC.
The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Sleepwizard.
Pre-market Notification Details
| Device ID | K964494 |
| 510k Number | K964494 |
| Device Name: | SLEEPWIZARD |
| Classification | Ventilatory Effort Recorder |
| Applicant | NELLCOR PURITAN BENNETT, INC. 10200 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Contact | Chris Hadland |
| Correspondent | Chris Hadland NELLCOR PURITAN BENNETT, INC. 10200 VALLEY VIEW RD. Eden Prairie, MN 55344 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-08 |
| Decision Date | 1997-02-04 |
| Summary: | summary |
Trademark Results [SLEEPWIZARD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SLEEPWIZARD 75142231 not registered Dead/Abandoned |
Nellcor Puritan Bennett Incorporated 1996-07-26 |
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