AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE— 510(k) K032278
Substantially EquivalentAmbu, Inc.
FDA 510(k) clearance K032278 for AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE, Substantially Equivalent on 2004-03-05. Applicant: Ambu, Inc.. Device class: 2.
Clearance details
- Applicant
- Ambu, Inc.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Linthicum, MD, US
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More clearances from Ambu, Inc.
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