The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Ems Pulmonary Function Testing Filter.
| Device ID | K013123 |
| 510k Number | K013123 |
| Device Name: | EMS PULMONARY FUNCTION TESTING FILTER |
| Classification | Spirometer, Diagnostic |
| Applicant | ENGINEERED MEDICAL SYSTEMS 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden ENGINEERED MEDICAL SYSTEMS 6329 W. WATERVIEW CT. Mccordsville, IN 46055 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-19 |
| Decision Date | 2002-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05030267161560 | K013123 | 000 |
| 05030267136049 | K013123 | 000 |
| 05030267135998 | K013123 | 000 |
| 05030267135820 | K013123 | 000 |
| 05030267135806 | K013123 | 000 |
| 05030267135783 | K013123 | 000 |
| 05030267135769 | K013123 | 000 |
| 05030267135738 | K013123 | 000 |
| 05030267135714 | K013123 | 000 |
| 05030267136094 | K013123 | 000 |
| 05030267146444 | K013123 | 000 |
| 05030267161027 | K013123 | 000 |
| 05030267160648 | K013123 | 000 |
| 05030267160594 | K013123 | 000 |
| 05030267160570 | K013123 | 000 |
| 05030267160457 | K013123 | 000 |
| 05030267160419 | K013123 | 000 |
| 05030267160525 | K013123 | 000 |
| 05030267146505 | K013123 | 000 |
| 00841470100230 | K013123 | 000 |