The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Modification Manual Pulmon Resuscitor/pulmanex(tm).
| Device ID | K913714 |
| 510k Number | K913714 |
| Device Name: | MODIFICATION MANUAL PULMON RESUSCITOR/PULMANEX(TM) |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | LIFE DESIGN SYSTEMS, INC. 2735 EAST BELT LINE RD. Carrollton, TX 75006 |
| Contact | James Antosh |
| Correspondent | James Antosh LIFE DESIGN SYSTEMS, INC. 2735 EAST BELT LINE RD. Carrollton, TX 75006 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-15 |
| Decision Date | 1992-12-01 |