The following data is part of a premarket notification filed by Diametrics Medical, Ltd. with the FDA for Trendcare Calibrator Model Scu 7007.
| Device ID | K983198 |
| 510k Number | K983198 |
| Device Name: | TRENDCARE CALIBRATOR MODEL SCU 7007 |
| Classification | Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling |
| Applicant | DIAMETRICS MEDICAL, LTD. SHORT STREET High Wycombe, Buckinghamshire, GB Hp11 2qh |
| Contact | Jan Walters |
| Correspondent | Jan Walters DIAMETRICS MEDICAL, LTD. SHORT STREET High Wycombe, Buckinghamshire, GB Hp11 2qh |
| Product Code | CCC |
| CFR Regulation Number | 868.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-11 |
| Decision Date | 1999-11-23 |
| Summary: | summary |