The following data is part of a premarket notification filed by Life Support Products, Inc. with the FDA for Lsp Minilator.
Device ID | K860516 |
510k Number | K860516 |
Device Name: | LSP MINILATOR |
Classification | Flowmeter, Calibration, Gas |
Applicant | LIFE SUPPORT PRODUCTS, INC. ONE MAUCHLY Irvine, CA 92718 |
Contact | Donald C Fabish |
Correspondent | Donald C Fabish LIFE SUPPORT PRODUCTS, INC. ONE MAUCHLY Irvine, CA 92718 |
Product Code | BXY |
CFR Regulation Number | 868.2350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-11 |
Decision Date | 1986-02-21 |