The following data is part of a premarket notification filed by Life Support Products, Inc. with the FDA for Automatic Ventilator Av2000.
Device ID | K874656 |
510k Number | K874656 |
Device Name: | AUTOMATIC VENTILATOR AV2000 |
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 | 1987-11-19 |
Decision Date | 1988-01-19 |