The following data is part of a premarket notification filed by American V. Mueller with the FDA for V. Mueller Blom-singer Esophageal Insufflation Tes.
| Device ID | K851082 |
| 510k Number | K851082 |
| Device Name: | V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES |
| Classification | Catheter, Nasopharyngeal |
| Applicant | AMERICAN V. MUELLER 6600 W. TOUHY Chicago, IL 60648 |
| Contact | Mathew Nowland |
| Correspondent | Mathew Nowland AMERICAN V. MUELLER 6600 W. TOUHY Chicago, IL 60648 |
| Product Code | ENW |
| CFR Regulation Number | 874.4175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-18 |
| Decision Date | 1985-07-22 |