The following data is part of a premarket notification filed by Portex Ltd. with the FDA for Portex Thermovent Hepa Hme Breathing Filter With Co2 Port (sterile And Non-sterile).
| Device ID | K032716 |
| 510k Number | K032716 |
| Device Name: | PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE) |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | PORTEX LTD. MILITARY ROAD Hythe, Kent, GB Ct 21 6jl |
| Contact | Steve Ogilvie |
| Correspondent | Steve Ogilvie PORTEX LTD. MILITARY ROAD Hythe, Kent, GB Ct 21 6jl |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-02 |
| Decision Date | 2003-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019315048351 | K032716 | 000 |
| 35019315048405 | K032716 | 000 |