510(k) K771188
K771188 is an FDA 510(k) premarket notification submitted by Teca, Inc. for the device "REVERSING CLICK GENERATOR RCG6". The FDA issued a decision of Substantially Equivalent on July 14, 1977. The device falls under product code ETS (Generator, Electronic Noise (For Audiometric Testing)), a Class II device regulated under 21 CFR 874.1120. Teca, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 14, 1977
- Date Received
- July 1, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Electronic Noise (For Audiometric Testing)
- Device Class
- Class II
- Regulation Number
- 874.1120
- Review Panel
- EN
- Submission Type