PULMANEX
Ventilator, Emergency, Manual (resuscitator)
LIFE DESIGN SYSTEMS, INC.
The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Pulmanex.
Pre-market Notification Details
| Device ID | K854037 |
| 510k Number | K854037 |
| Device Name: | PULMANEX |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | LIFE DESIGN SYSTEMS, INC. 11017 WEST LAYTON AVE. Milwaukee, WI 53228 |
| Contact | Gilbert M Kirk |
| Correspondent | Gilbert M Kirk LIFE DESIGN SYSTEMS, INC. 11017 WEST LAYTON AVE. Milwaukee, WI 53228 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-11 |
| Decision Date | 1985-11-01 |
Trademark Results [PULMANEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PULMANEX 75319828 2173012 Dead/Cancelled |
VIASYS HOLDINGS INC. 1997-07-07 |
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