The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Quazar Esophageal Stethoscope.
| Device ID | K841574 |
| 510k Number | K841574 |
| Device Name: | QUAZAR ESOPHAGEAL STETHOSCOPE |
| Classification | Stethoscope, Esophageal |
| Applicant | AXIOM MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZW |
| CFR Regulation Number | 868.1910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-17 |
| Decision Date | 1984-08-15 |