K960916 is an FDA 510(k) clearance for the SAMS 8000 CARDIOPLEGIA MONITOR. This device is classified as a Alarm, Blood-pressure (Class II - Special Controls, product code DSJ).
Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on June 4, 1996, 90 days after receiving the submission on March 6, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1100.
| 510(k) Number | K960916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 1996 |
| Decision Date | June 04, 1996 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSJ — Alarm, Blood-pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1100 |