The following data is part of a premarket notification filed by Western/scott Fetzer Co. with the FDA for Oxytote Infinity Series Vipr Systems.
| Device ID | K142149 |
| 510k Number | K142149 |
| Device Name: | OXYTOTE INFINITY SERIES VIPR SYSTEMS |
| Classification | Cylinder, Compressed Gas, And Valve |
| Applicant | WESTERN/SCOTT FETZER CO. 875 BASSETT RD. Westlake, OH 44145 -1142 |
| Contact | David C Simo |
| Correspondent | David C Simo WESTERN/SCOTT FETZER CO. 875 BASSETT RD. Westlake, OH 44145 -1142 |
| Product Code | ECX |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-05 |
| Decision Date | 2015-04-17 |
| Summary: | summary |