The following data is part of a premarket notification filed by Instrumentarium Corp. with the FDA for Tonometered Slaine Blood Gas Control.
| Device ID | K961441 |
| 510k Number | K961441 |
| Device Name: | TONOMETERED SLAINE BLOOD GAS CONTROL |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | INSTRUMENTARIUM CORP. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Contact | Joel C Kent |
| Correspondent | Joel C Kent INSTRUMENTARIUM CORP. 2 HIGHWOOD DR. Tewksbury, MA 01876 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-15 |
| Decision Date | 1996-04-30 |