The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Ems Electrostatic Fliter And Hme Combination.
| Device ID | K013122 |
| 510k Number | K013122 |
| Device Name: | EMS ELECTROSTATIC FLITER AND HME COMBINATION |
| 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 | 2001-09-19 |
| Decision Date | 2002-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841470110055 | K013122 | 000 |
| 00841470110079 | K013122 | 000 |
| 00841470109868 | K013122 | 000 |
| 10841470108073 | K013122 | 000 |
| 00841470108007 | K013122 | 000 |
| 00841470103453 | K013122 | 000 |
| 10841470103443 | K013122 | 000 |
| 10841470103436 | K013122 | 000 |
| 10841470100985 | K013122 | 000 |
| 00841470110376 | K013122 | 000 |
| 10841470110441 | K013122 | 000 |
| 10841470109810 | K013122 | 000 |
| 00841470110741 | K013122 | 000 |
| 00841470110734 | K013122 | 000 |
| 10841470110519 | K013122 | 000 |
| 10841470110496 | K013122 | 000 |
| 10841470110489 | K013122 | 000 |
| 10841470110472 | K013122 | 000 |
| 10841470110458 | K013122 | 000 |
| 10841470100220 | K013122 | 000 |