510(k) K896710
K896710 is an FDA 510(k) premarket notification submitted by Madsen North America, Inc. for the device "MIDIMATE 622". The FDA issued a decision of Substantially Equivalent on April 13, 1990. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Madsen North America, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 1990
- Date Received
- November 28, 1989
- 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