The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns Ultrasonic Air Sensor.
Device ID | K940651 |
510k Number | K940651 |
Device Name: | SARNS ULTRASONIC AIR SENSOR |
Classification | Detector, Bubble, Cardiopulmonary Bypass |
Applicant | 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Contact | Timothy J Kriewall, Ph.d. |
Correspondent | Timothy J Kriewall, Ph.d. 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor, MI 48106 |
Product Code | KRL |
CFR Regulation Number | 870.4205 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-02-15 |
Decision Date | 1994-05-24 |