The following data is part of a premarket notification filed by Sims Portex, Inc. with the FDA for Electrostatic Hydrophobic Breathing Filter.
| Device ID | K002201 |
| 510k Number | K002201 |
| Device Name: | ELECTROSTATIC HYDROPHOBIC BREATHING FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | SIMS PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Timothy J Talcott |
| Correspondent | Timothy J Talcott SIMS PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-20 |
| Decision Date | 2001-02-05 |