The following data is part of a premarket notification filed by J. Sklar Mfg. Co., Inc. with the FDA for Leff Stethoscope For Fetal Heart.
| Device ID | K761338 |
| 510k Number | K761338 |
| Device Name: | LEFF STETHOSCOPE FOR FETAL HEART |
| Classification | Stethoscope, Fetal |
| Applicant | J. SKLAR MFG. CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HGN |
| CFR Regulation Number | 884.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-12-27 |
| Decision Date | 1977-01-12 |