ASC-954 INTEGRATOR AMPLIFIER
FDA 510(k) clearance K896164 · decided 1990-01-22
Clearance details
- K-number
- K896164
- Device name
- ASC-954 INTEGRATOR AMPLIFIER
- Applicant
- Astro-Med, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-10-24
- Decision date
- 1990-01-22
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- GWK
- Device class
- 2
- Regulation number
- 882.1845
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- West Warwick, RI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.