The following data is part of a premarket notification filed by Critisense Ltd. with the FDA for Critiview, Model Crv3.
| Device ID | K062977 |
| 510k Number | K062977 |
| Device Name: | CRITIVIEW, MODEL CRV3 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | CRITISENSE LTD. 3460 POINTE CREEK CT. # 102 Bonita Springs, FL 34134 -2015 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden CRITISENSE LTD. 3460 POINTE CREEK CT. # 102 Bonita Springs, FL 34134 -2015 |
| Product Code | DPW |
| Subsequent Product Code | EZL |
| Subsequent Product Code | KHO |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-29 |
| Decision Date | 2007-02-28 |
| Summary: | summary |