510(k) K935146
K935146 is an FDA 510(k) premarket notification submitted by Modern Medical Devices, Inc. for the device "DISPOSABLE STETHOSCOPE HEAD COVER". The FDA issued a decision of Substantially Equivalent on July 11, 1994. The device falls under product code BZS (Stethoscope Head), a Class I device regulated under 21 CFR 868.1930.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 1994
- Date Received
- October 28, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stethoscope Head
- Device Class
- Class I
- Regulation Number
- 868.1930
- Review Panel
- AN
- Submission Type