The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Air Detection System.
| Device ID | K935977 |
| 510k Number | K935977 |
| Device Name: | SARNS AIR DETECTION SYSTEM |
| Classification | Detector, Bubble, Cardiopulmonary Bypass |
| Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Denise D Shimokochi |
| Correspondent | Denise D Shimokochi 3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Product Code | KRL |
| CFR Regulation Number | 870.4205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-13 |
| Decision Date | 1994-02-04 |