| Device Type ID | 68 |
| Device Name | Spirometer, Diagnostic |
| Regulation Description | Diagnostic 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 | 868.1840 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | BZG |
| 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 | 68 |
| Device | Spirometer, Diagnostic |
| Product Code | BZG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Spirometer. |
| CFR Regulation Number | 868.1840 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CAREFUSION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ERESEARCH TECHNOLOGY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FIM MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GANSHORN MEDIZIN ELECTRONIC GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDICAL RESPIRATORY DEVICES S.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDIKRO OY | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MONITORED THERAPEUTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NDD MEDIZITECHNIK AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PULMONE ADVANCED MEDICAL DEVICES, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PULMONX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SDI DIAGNOSTICS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VITALOGRAPH(IRELAND) LTD. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |