ALICE
FDA 510(k) clearance K922106 · decided 1994-07-06
Clearance details
- K-number
- K922106
- Device name
- ALICE
- Applicant
- Healthdyne, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-05
- Decision date
- 1994-07-06
- Days to decision
- 792 days
- Clearance type
- Traditional
- Product code
- OLV
- Device class
- 2
- Regulation number
- 882.1400
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Marietta, GA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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