Atlas FDA

CAPIOX LEVEL ALARM

FDA 510(k) clearance K915337 · decided 1992-02-21

Clearance details

K-number
K915337
Device name
CAPIOX LEVEL ALARM
Applicant
Terumo Medical Corp.
Decision
Substantially Equivalent
Date received
1991-11-26
Decision date
1992-02-21
Days to decision
87 days
Clearance type
Traditional
Product code
DTW
Device class
2
Regulation number
870.4340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Elkton, MD, US
Third-party review
No
Expedited review
No

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CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR (K910599)Jtl Medical Corp.1993-05-20
STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR (K924354)Sorin Biomedica, Fiat, USA, Inc.1993-02-18
COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) (K900910)Cobe Laboratories, Inc.1990-05-22
SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL (K900815)3M Company1990-05-09
MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE (K873206)Respiratory Support Products, Inc.1987-09-30
GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 (K860076)Gambro, Inc.1986-05-30
SENSOR TAPE CAT. NO. ST-45 (K852407)American Omni Medical, Inc.1985-10-21
STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR (K843802)Shiley, Inc.1984-12-27

Recalls involving this device

No recalls on record reference this clearance.