The following data is part of a premarket notification filed by Clinical Data, Inc. with the FDA for Centurion-ii, Model 3103 Apnea/brady Cardia Trachy.
| Device ID | K851889 |
| 510k Number | K851889 |
| Device Name: | CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY |
| Classification | Monitor, Breathing Frequency |
| Applicant | CLINICAL DATA, INC. 1172 COMMONWEALTH AVE. Boston, MA 02134 |
| Contact | Israel M Stein |
| Correspondent | Israel M Stein CLINICAL DATA, INC. 1172 COMMONWEALTH AVE. Boston, MA 02134 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-30 |
| Decision Date | 1985-10-23 |