The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Softech Plus Etc02 Cannula.
| Device ID | K132946 |
| 510k Number | K132946 |
| Device Name: | SOFTECH PLUS ETC02 CANNULA |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Angela Bouse |
| Correspondent | Angela Bouse Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-19 |
| Decision Date | 2014-06-04 |
| Summary: | summary |