CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN
FDA 510(k) clearance K884991 · decided 1989-06-06
Clearance details
- K-number
- K884991
- Device name
- CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN
- Applicant
- Datex Division Instrumentarium Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-12-01
- Decision date
- 1989-06-06
- Days to decision
- 187 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Helsinki, Finland, FI
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.