The following data is part of a premarket notification filed by Essex Cryogenics Of Missouri, Inc. with the FDA for Portable Therapeutic Liquid Oxygen Unit.
Device ID | K880183 |
510k Number | K880183 |
Device Name: | PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT |
Classification | Unit, Liquid-oxygen, Portable |
Applicant | ESSEX CRYOGENICS OF MISSOURI, INC. 8007 CHIVVIS DR. St. Louis, MO 63123 |
Contact | Fred Snyder |
Correspondent | Fred Snyder ESSEX CRYOGENICS OF MISSOURI, INC. 8007 CHIVVIS DR. 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 | 1988-01-15 |
Decision Date | 1988-04-14 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10815363020025 | K880183 | 000 |