The following data is part of a premarket notification filed by Life Support Products, Inc. with the FDA for Lspi Automatic Ventilator, Model Av2000-100.
| Device ID | K941870 |
| 510k Number | K941870 |
| Device Name: | LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100 |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | LIFE SUPPORT PRODUCTS, INC. 1720 SUBLETTE AVE. St Louis, MO 63110 |
| Contact | Vernon Trimble |
| Correspondent | Vernon Trimble LIFE SUPPORT PRODUCTS, INC. 1720 SUBLETTE AVE. St Louis, MO 63110 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-18 |
| Decision Date | 1995-01-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720000807 | K941870 | 000 |
| 00026072000809 | K941870 | 000 |