The following data is part of a premarket notification filed by Sims Portex, Inc. with the FDA for Breathing Filter For Disposable Anesthesia Breathing Circuit.
| Device ID | K002506 |
| 510k Number | K002506 |
| Device Name: | BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT |
| 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 | 2000-08-15 |
| Decision Date | 2000-12-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35019517094897 | K002506 | 000 |
| 35019517093739 | K002506 | 000 |