The following data is part of a premarket notification filed by Life Support Products, Inc. with the FDA for Lsp Disposable Bag Resuscitator, Model 470.
Device ID | K874418 |
510k Number | K874418 |
Device Name: | LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470 |
Classification | Ventilator, Emergency, Manual (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 | BTM |
CFR Regulation Number | 868.5915 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-28 |
Decision Date | 1988-01-22 |