Definition: To Assist The User With Refilling A Portable Liquid Oxygen Tank From A Reservoir Unit By Holding The Portable Liquid Oxygen Tank In An Upright Position.
Device Type ID | 221 |
Device Name | Portable Liquid Oxygen Unit Stand |
Physical State | Portable Liquid Oxygen Unit |
Technical Method | Physically Maintains The Portable Liquid Oxygen Tank In An Upright Position |
Target Area | Portable Liquid Oxygen Tanks And Reservoir Units |
Regulation Description | Daily Activity Assist Device. |
Regulation Medical Specialty | Physical Medicine |
Review Panel | Anesthesiology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Anesthesiology Devices Branch (ANDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 890.5050 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | PCM |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 221 |
Device | Portable Liquid Oxygen Unit Stand |
Product Code | PCM |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Daily Activity Assist Device. |
CFR Regulation Number | 890.5050 [🔎] |