The following data is part of a premarket notification filed by Graham-field, Inc. with the FDA for Labtron Electromax Electronic Stethoscope Model No. 04-1060.
| Device ID | K961857 |
| 510k Number | K961857 |
| Device Name: | LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060 |
| Classification | Stethoscope, Electronic |
| Applicant | GRAHAM-FIELD, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk GRAHAM-FIELD, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-14 |
| Decision Date | 1996-07-03 |
| Summary: | summary |