The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Abco Pediatric Stethoscope.
Device ID | K801215 |
510k Number | K801215 |
Device Name: | ABCO PEDIATRIC STETHOSCOPE |
Classification | Stethoscope, Manual |
Applicant | ABCO DEALERS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LDE |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-05-20 |
Decision Date | 1980-06-04 |