The following data is part of a premarket notification filed by Critikon Company,llc with the FDA for Critikon Central Statin Monitor.
| Device ID | K933404 |
| 510k Number | K933404 |
| Device Name: | CRITIKON CENTRAL STATIN MONITOR |
| Classification | Electrocardiograph |
| Applicant | CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
| Contact | Annette M Hillring |
| Correspondent | Annette M Hillring CRITIKON COMPANY,LLC 4110 GEORGE RD. P.O. BOX 31800 Tampa, FL 33631 -3800 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-12 |
| Decision Date | 1994-02-09 |