The following data is part of a premarket notification filed by Life Design Systems, Inc. with the FDA for Pulmonary Resuscitator, Modification.
| Device ID | K892221 |
| 510k Number | K892221 |
| Device Name: | PULMONARY RESUSCITATOR, MODIFICATION |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | LIFE DESIGN SYSTEMS, INC. 5900 WEST FRANKLIN DR. Franklin, WI 53132 |
| Contact | Alan E Whitmarsh |
| Correspondent | Alan E Whitmarsh LIFE DESIGN SYSTEMS, INC. 5900 WEST FRANKLIN DR. Franklin, WI 53132 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-30 |
| Decision Date | 1989-05-18 |