The following data is part of a premarket notification filed by Qserve America, Inc. with the FDA for Medisize Red And Medisize Blue.
| Device ID | K110246 |
| 510k Number | K110246 |
| Device Name: | MEDISIZE RED AND MEDISIZE BLUE |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | QSERVE AMERICA, INC. 220 RIVER RD. Claremont, NH 03743 -5647 |
| Contact | William Greenrose |
| Correspondent | William Greenrose QSERVE AMERICA, INC. 220 RIVER RD. Claremont, NH 03743 -5647 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-27 |
| Decision Date | 2011-11-04 |