The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Pulmanex Tm (modification).
| Device ID | K863026 |
| 510k Number | K863026 |
| Device Name: | PULMANEX TM (MODIFICATION) |
| 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 | 1986-08-11 |
| Decision Date | 1986-08-26 |