510(k) K911726
K911726 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION". The FDA issued a decision of Substantially Equivalent on October 23, 1991. The device falls under product code KHL (Hearing Aid, Master), a Class II device regulated under 21 CFR 874.3330. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1991
- Date Received
- April 11, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hearing Aid, Master
- Device Class
- Class II
- Regulation Number
- 874.3330
- Review Panel
- EN
- Submission Type