SANDMAN POCKET
Ventilatory Effort Recorder
EB NEURO, S.P.A.
The following data is part of a premarket notification filed by Eb Neuro, S.p.a. with the FDA for Sandman Pocket.
Pre-market Notification Details
| Device ID | K061996 |
| 510k Number | K061996 |
| Device Name: | SANDMAN POCKET |
| Classification | Ventilatory Effort Recorder |
| Applicant | EB NEURO, S.P.A. 11460 N. MERIDIAN ST. SUITE 150 Carmel, IN 46032 |
| Contact | Carri Graham |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-07-14 |
| Decision Date | 2006-10-03 |
| Summary: | summary |
Trademark Results [SANDMAN POCKET]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SANDMAN POCKET 78597287 not registered Dead/Abandoned |
Nellcor Puritan Bennett Incorporated 2005-03-29 |
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