510(k) K031713
K031713 is an FDA 510(k) premarket notification submitted by Viasys Healthcare, Inc. for the device "AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS". The FDA issued a decision of Substantially Equivalent on August 12, 2003. The device falls under product code EWO (Audiometer), a Class II device regulated under 21 CFR 874.1050. Viasys Healthcare, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2003
- Date Received
- June 2, 2003
- 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