The following data is part of a premarket notification filed by Modern Medical Devices, Inc. with the FDA for Disposable Stethoscope Head Cover.
| Device ID | K935146 |
| 510k Number | K935146 |
| Device Name: | DISPOSABLE STETHOSCOPE HEAD COVER |
| Classification | Stethoscope Head |
| Applicant | MODERN MEDICAL DEVICES, INC. 42307 OSGOOD RD. STE. N Fremont, CA 94539 |
| Contact | Leslie E Manzanilla |
| Correspondent | Leslie E Manzanilla MODERN MEDICAL DEVICES, INC. 42307 OSGOOD RD. STE. N Fremont, CA 94539 |
| Product Code | BZS |
| CFR Regulation Number | 868.1930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-28 |
| Decision Date | 1994-07-11 |