The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Iso-gard Clearair Mask.
| Device ID | K123176 |
| 510k Number | K123176 |
| Device Name: | ISO-GARD CLEARAIR MASK |
| Classification | Apparatus, Gas-scavenging |
| Applicant | Teleflex Medical, Inc. 2917 WECK DR. PO BOX 12600 Research Triangle Park, NC 27709 |
| Contact | Angela Bouse |
| Correspondent | Angela Bouse Teleflex Medical, Inc. 2917 WECK DR. PO BOX 12600 Research Triangle Park, NC 27709 |
| Product Code | CBN |
| CFR Regulation Number | 868.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-10 |
| Decision Date | 2013-02-14 |
| Summary: | summary |