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 |