The following data is part of a premarket notification filed by Viasys Medsystems with the FDA for Stackhouse Freedomaire Ii Surgical Helmet System, Models 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031.
| Device ID | K043004 |
| 510k Number | K043004 |
| Device Name: | STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 |
| Classification | Gown, Surgical |
| Applicant | VIASYS MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090 |
| Contact | Stephanie Wasielewski |
| Correspondent | Stephanie Wasielewski VIASYS MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-01 |
| Decision Date | 2005-03-16 |