510(k) K030823 ยท GWJ Stimulator, Auditory, Evoked Response
ALGO 3I NEWBORN HEARING SCREENER
| Applicant | Natus Medical, Inc., San Carlos CA, US |
| Decision | Substantially Equivalent, Apr 9, 2003 |
| Received | Mar 14, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030823
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2005 | Natus Medical Inc Natus Algo Pre-Amplifier 3 cable assembly (Component of the Algo 3 Newborn Hearing Screener and Algo 3i Newborn Hearing screener, Algo Portable Newborn Hearing Screener, and Algo 2ec Newborn Hearing S Terminated |
ETY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.