The following data is part of a premarket notification filed by Inspiron Corp. with the FDA for Inspiron Liquid Oxygen System.
Device ID | K834290 |
510k Number | K834290 |
Device Name: | INSPIRON LIQUID OXYGEN SYSTEM |
Classification | Unit, Liquid-oxygen, Portable |
Applicant | INSPIRON CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | BYJ |
CFR Regulation Number | 868.5655 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-08 |
Decision Date | 1984-02-04 |