Device Type ID | 150 |
Device Name | Accessory To Continuous Ventilator (respirator) |
Regulation Description | Continuous Ventilator. |
Regulation Medical Specialty | Anesthesiology |
Review Panel | Anesthesiology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Respiratory Devices Branch (RPDB) |
Submission Type | 510(k) |
CFR Regulation Number | 868.5895 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MOD |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 150 |
Device | Accessory To Continuous Ventilator (respirator) |
Product Code | MOD |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Continuous Ventilator. |
CFR Regulation Number | 868.5895 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RESPIRONICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 |