510(k) K953684
K953684 is an FDA 510(k) premarket notification submitted by Grason-Stadler, Inc. for the device "GSI 61 CLINICAL AUDIOMETER". The FDA issued a decision of Substantially Equivalent on October 27, 1995. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Grason-Stadler, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 1995
- Date Received
- August 3, 1995
- 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