The following data is part of a premarket notification filed by Mallinckrodt Medical with the FDA for Esophageal Stethoscope W/temp Sensor/gastric Suct.
| Device ID | K914887 |
| 510k Number | K914887 |
| Device Name: | ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR/GASTRIC SUCT |
| Classification | Tube, Levine |
| Applicant | MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Contact | Jeffery W Biggers |
| Correspondent | Jeffery W Biggers MALLINCKRODT MEDICAL 675 MCDONNELL BLVD. P.O. BOX 5840 St. Louis, MO 63134 |
| Product Code | FRQ |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-30 |
| Decision Date | 1992-05-08 |