The following data is part of a premarket notification filed by Critisense Ltd. with the FDA for Critiview.
| Device ID | K051145 |
| 510k Number | K051145 |
| Device Name: | CRITIVIEW |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | CRITISENSE LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden CRITISENSE LTD. 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-04 |
| Decision Date | 2006-01-18 |
| Summary: | summary |