The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc. with the FDA for Model 405t With Etco2 Option.
| Device ID | K964961 |
| 510k Number | K964961 |
| Device Name: | MODEL 405T WITH ETCO2 OPTION |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
| Contact | Dick Listro |
| Correspondent | Dick Listro IVY BIOMEDICAL SYSTEMS, INC. 11 BUSINESS PARK DR. Branford, CT 06405 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-11 |
| Decision Date | 1997-05-14 |