STATVIEW SYSTEM
FDA 510(k) clearance K990378 · decided 1999-09-20
Clearance details
- K-number
- K990378
- Device name
- STATVIEW SYSTEM
- Applicant
- Data Critical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-02-08
- Decision date
- 1999-09-20
- Days to decision
- 224 days
- Clearance type
- Traditional
- Product code
- MSX
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.