| Device Type ID | 81 |
| Device Name | Vaporizer, Anesthesia, Non-heated |
| Regulation Description | Anesthetic Vaporizer. |
| 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) Anesthesiology Devices Branch (ANDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.5880 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CAD |
| 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 | 81 |
| Device | Vaporizer, Anesthesia, Non-heated |
| Product Code | CAD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Anesthetic Vaporizer. |
| CFR Regulation Number | 868.5880 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DATEX-OHMEDA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Inoperable | 11 |
Device Operates Differently Than Expected | 9 |
Appropriate Term/Code Not Available | 6 |
Infusion Or Flow Problem | 5 |
Leak / Splash | 4 |
Break | 3 |
Mechanical Problem | 3 |
Component Missing | 3 |
High Readings | 3 |
Pin | 2 |
Unexpected Therapeutic Results | 2 |
Output Problem | 2 |
Insufficient Flow Or Under Infusion | 2 |
Safety Interlock | 2 |
Locking Mechanism | 2 |
Vaporizer | 1 |
Computer Operating System Problem | 1 |
Mechanical Jam | 1 |
Power Cord | 1 |
Low Test Results | 1 |
Connector Pin | 1 |
Loose Or Intermittent Connection | 1 |
Inaccurate Delivery | 1 |
Connection Problem | 1 |
Self-Activation Or Keying | 1 |
No Flow | 1 |
| Total Device Problems | 70 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Draeger Medical, Inc. | II | May-25-2016 |
| 2 | GE Healthcare, LLC | II | Mar-26-2018 |