The following data is part of a premarket notification filed by Bhs Intl., Inc. with the FDA for Manual Stetoscope.
| Device ID | K940578 |
| 510k Number | K940578 |
| Device Name: | MANUAL STETOSCOPE |
| Classification | Stethoscope, Manual |
| Applicant | BHS INTL., INC. 2431 CROFTON LN., SUITE 9 Crofton, MD 21114 |
| Contact | Heather Wallace |
| Correspondent | Heather Wallace BHS INTL., INC. 2431 CROFTON LN., SUITE 9 Crofton, MD 21114 |
| Product Code | LDE |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-08 |
| Decision Date | 1994-04-26 |