510(k) K934343
K934343 is an FDA 510(k) premarket notification submitted by Glaser Instruments AG for the device "GLASER RT60, RT80, RT150 AUDIOMETER". The FDA issued a decision of Substantially Equivalent on January 21, 1994. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Glaser Instruments AG has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1994
- Date Received
- September 7, 1993
- 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