The following data is part of a premarket notification filed by Life Support Products, Inc. with the FDA for Mask, Oxygen.
Device ID | K874092 |
510k Number | K874092 |
Device Name: | MASK, OXYGEN |
Classification | Mask, Oxygen |
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 | BYG |
CFR Regulation Number | 868.5580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-08 |
Decision Date | 1988-02-11 |