The following data is part of a premarket notification filed by Life Corp. with the FDA for Life Oxygenpac 6/12 Lpm.
| Device ID | K910435 |
| 510k Number | K910435 |
| Device Name: | LIFE OXYGENPAC 6/12 LPM |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | LIFE CORP. P.O. BOX 300 W140 N5566 LILLY ROAD Menomonee Falls, WI 53051 |
| Contact | John Kirchgeorg |
| Correspondent | John Kirchgeorg LIFE CORP. P.O. BOX 300 W140 N5566 LILLY ROAD Menomonee Falls, WI 53051 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-31 |
| Decision Date | 1991-06-17 |