510(k) K030823
K030823 is an FDA 510(k) premarket notification submitted by Natus Medical, Inc. for the device "ALGO 3I NEWBORN HEARING SCREENER". The FDA issued a decision of Substantially Equivalent on April 9, 2003. The device falls under product code GWJ (Stimulator, Auditory, Evoked Response), a Class II device regulated under 21 CFR 882.1900. Natus Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2003
- Date Received
- March 14, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Auditory, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1900
- Review Panel
- NE
- Submission Type