The following data is part of a premarket notification filed by Life Support Products, Inc. with the FDA for Lsp Automatic Ventilator, Model 456.
Device ID | K870424 |
510k Number | K870424 |
Device Name: | LSP AUTOMATIC VENTILATOR, MODEL 456 |
Classification | Ventilator, Emergency, Powered (resuscitator) |
Applicant | LIFE SUPPORT PRODUCTS, INC. ONE MAUCHLY Irvine, CA 92718 |
Contact | Tom Fangrow |
Correspondent | Tom 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 | 1987-02-03 |
Decision Date | 1988-01-22 |