The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sams 8000 Cardioplegia Monitor.
| Device ID | K960916 |
| 510k Number | K960916 |
| Device Name: | SAMS 8000 CARDIOPLEGIA MONITOR |
| Classification | Alarm, Blood-pressure |
| Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Cheryl Rosenberg |
| Correspondent | Cheryl Rosenberg 3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Product Code | DSJ |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DWB |
| CFR Regulation Number | 870.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-06 |
| Decision Date | 1996-06-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886799001721 | K960916 | 000 |
| 00886799000342 | K960916 | 000 |
| 00886799000236 | K960916 | 000 |
| 00886799000229 | K960916 | 000 |
| 00886799000212 | K960916 | 000 |