| Device Type ID | 70 |
| Device Name | Spirometer, Monitoring (w/wo Alarm) |
| Regulation Description | Monitoring Spirometer. |
| 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 | 868.1850 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BZK |
| 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 | 70 |
| Device | Spirometer, Monitoring (w/wo Alarm) |
| Product Code | BZK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Monitoring Spirometer. |
| CFR Regulation Number | 868.1850 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
RESPIRATORY MOTION, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Mindray DS USA, Inc. Dba Mindray North America | III | Mar-28-2018 |