510(k) K880259
K880259 is an FDA 510(k) premarket notification submitted by Colorado Hearing Systems, Inc. for the device "VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV". The FDA issued a decision of Substantially Equivalent on April 3, 1989. The device falls under product code LYN (Apparatus, Visual Reinforcement Audiometric), a Class II device regulated under 21 CFR 874.1050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 3, 1989
- Date Received
- January 22, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Visual Reinforcement Audiometric
- Device Class
- Class II
- Regulation Number
- 874.1050
- Review Panel
- EN
- Submission Type