The following data is part of a premarket notification filed by Amdia Medical Products with the FDA for Bowles Stethoscope.
Device ID | K791333 |
510k Number | K791333 |
Device Name: | BOWLES STETHOSCOPE |
Classification | Stethoscope, Electronic |
Applicant | AMDIA MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DQD |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-07-20 |
Decision Date | 1979-08-10 |