MONITOR KITS, BLOOD LEVEL
Device Facts
| Record ID | K781145 |
|---|---|
| Device Name | MONITOR KITS, BLOOD LEVEL |
| Applicant | 3M Health Care, Sarns |
| Product Code | DTW · Cardiovascular |
| Decision Date | Jul 27, 1978 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4340 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
