The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Ems Hepa Filter And Hme Combinations.
| Device ID | K013089 |
| 510k Number | K013089 |
| Device Name: | EMS HEPA FILTER AND HME COMBINATIONS |
| Classification | Filter, Bacterial, Breathing-circuit |
| 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 | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-17 |
| Decision Date | 2002-03-14 |
| Summary: | summary |