SEQUENCER
FDA 510(k) clearance K981313 · decided 1998-07-09
Clearance details
- K-number
- K981313
- Device name
- SEQUENCER
- Applicant
- Impac Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-10
- Decision date
- 1998-07-09
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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