The following data is part of a premarket notification filed by Ventrex, Inc. with the FDA for Coverox Sheath Models Number Ps65, Ps67, Eps65 And Eps67.
| Device ID | K964821 |
| 510k Number | K964821 |
| Device Name: | COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67 |
| Classification | Oximeter |
| Applicant | VENTREX, INC. 3007 BUNSEN AVE., UNIT L & K Ventura, CA 93003 |
| Contact | Robert B Guthrie |
| Correspondent | Robert B Guthrie VENTREX, INC. 3007 BUNSEN AVE., UNIT L & K Ventura, CA 93003 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-02 |
| Decision Date | 1997-07-16 |