The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Humid-vent Hepa.
| Device ID | K112958 |
| 510k Number | K112958 |
| Device Name: | HUMID-VENT HEPA |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | TELEFLEX MEDICAL 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Liz Paul |
| Correspondent | Liz Paul TELEFLEX MEDICAL 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-05 |
| Decision Date | 2012-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704400816 | K112958 | 000 |
| 44026704400797 | K112958 | 000 |