The following data is part of a premarket notification filed by Essex Industries, Inc. with the FDA for Mounted Medical Oxygen System.
Device ID | K113767 |
510k Number | K113767 |
Device Name: | MOUNTED MEDICAL OXYGEN SYSTEM |
Classification | Unit, Liquid-oxygen, Portable |
Applicant | ESSEX INDUSTRIES, INC. 8007 CHIVVIS DRIVE St. Louis, MO 63123 |
Contact | Ken Seise |
Correspondent | Ken Seise ESSEX INDUSTRIES, INC. 8007 CHIVVIS DRIVE St. Louis, MO 63123 |
Product Code | BYJ |
CFR Regulation Number | 868.5655 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-12-21 |
Decision Date | 2012-06-29 |
Summary: | summary |