The following data is part of a premarket notification filed by Life Support Products, Inc. with the FDA for Lspi Automatic Ventilator, Model Av3000.
| Device ID | K932199 |
| 510k Number | K932199 |
| Device Name: | LSPI AUTOMATIC VENTILATOR, MODEL AV3000 |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | LIFE SUPPORT PRODUCTS, INC. ONE MAUCHLY Irvine, CA 92718 |
| Contact | Thomas Fangrow |
| Correspondent | Thomas Fangrow LIFE SUPPORT PRODUCTS, INC. ONE MAUCHLY Irvine, CA 92718 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-06 |
| Decision Date | 1993-11-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720000876 | K932199 | 000 |
| 00260720000814 | K932199 | 000 |
| 00026072000878 | K932199 | 000 |
| 00026072000816 | K932199 | 000 |