The following data is part of a premarket notification filed by Andonian Cryogenics, Inc. with the FDA for Liquid Oxygen Unit, Portable 73byj.
Device ID | K780098 |
510k Number | K780098 |
Device Name: | LIQUID OXYGEN UNIT, PORTABLE 73BYJ |
Classification | Unit, Liquid-oxygen, Portable |
Applicant | ANDONIAN CRYOGENICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BYJ |
CFR Regulation Number | 868.5655 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-01-19 |
Decision Date | 1978-03-02 |