The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Tonocap, Tc-200 And Accessory Catheters.
| Device ID | K962638 |
| 510k Number | K962638 |
| Device Name: | TONOCAP, TC-200 AND ACCESSORY CATHETERS |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | INSTRUMENTARIUM CORP. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel Kent |
| Correspondent | Joel Kent INSTRUMENTARIUM CORP. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | CCK |
| Subsequent Product Code | CBR |
| Subsequent Product Code | KNT |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-05 |
| Decision Date | 1997-04-04 |