Atlas FDA

Quantum Workstation 12.1

FDA 510(k) clearance K181923 · decided 2018-08-17

Clearance details

K-number
K181923
Device name
Quantum Workstation 12.1
Applicant
Spectrum Medical , Ltd.
Decision
Substantially Equivalent
Date received
2018-07-18
Decision date
2018-08-17
Days to decision
30 days
Clearance type
Special
Product code
DRY
Device class
2
Regulation number
870.4330
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Gloucester, GB
Third-party review
No
Expedited review
No

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CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K133658)Terumo Cardiovascular Systems Corp.2014-07-25
CDI BLOOD PARAMETER MONITORING SYSTEM 500 (K123039)Terumo Cardiovascular Systems Corp.2012-11-20
M4 MONITOR (K110957)Spectrum Medical, Llp2011-05-31
B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) (K103168)Sorin Group Deutschland GmbH2011-01-06
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Recalls involving this device

No recalls on record reference this clearance.