510(k) K971080
K971080 is an FDA 510(k) premarket notification submitted by Bernafon-Maico, Inc. for the device "MAICO MA52". The FDA issued a decision of Substantially Equivalent on June 6, 1997. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Bernafon-Maico, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 1997
- Date Received
- March 25, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Audiometer
- Device Class
- Class II
- Regulation Number
- 874.1050
- Review Panel
- EN
- Submission Type