INTERACOUSTICS EP 15 ABR STAND ALONE UNIT— 510(k) K991853
Substantially EquivalentIdem (Int'L Dist. of Electronics For Medicine)
FDA 510(k) clearance K991853 for INTERACOUSTICS EP 15 ABR STAND ALONE UNIT, Substantially Equivalent on 1999-10-25. Applicant: Idem (Int'L Dist. of Electronics For Medicine). Device class: 2.
Clearance details
- Applicant
- Idem (Int'L Dist. of Electronics For Medicine)
- Product code
- Code GWJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1900
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Benicia, CA, US
Recent devices under product code GWJ
view allMore clearances from Idem (Int'L Dist. of Electronics For Medicine)
view all- K990585 — INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER
- K990652 — INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER
- K983832 — INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER
- K982249 — INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER
- K981327 — INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.