510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Dixtal Medical, Inc.

Wallingford, CT, US

Dixtal Medical, Inc. appears in FDA device records in Wallingford, CT. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
3
Registered establishments
0

510(k) clearance history

FDA records hold 2 510(k) clearances for Dixtal Medical, Inc. between 2010 and 2011. The busiest year on record is 2010, with 1. The most recent is 2011, with 1.

Clearances by year, as a table
510(k) clearance decisions for Dixtal Medical, Inc., by decision year
YearClearances
20101
20111
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K103285DIXTAL DZ-4100 SERIES PULSE OXIMETERDQASubstantially Equivalent
K100020DX SERIES FINGER SENSORDQASubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0551-2011Dixtal Handheld Pulse Oximetry Model 512 Catalog Number: 9100-00Unit may overestimate Sp02 levels in a high humidity environment.Terminated
Z-0550-2011Dixtal Handheld Pulse Oximetry Model 513 Catalog Number: 9300-00Unit may overestimate Sp02 levels in a high humidity environment.Terminated
Z-1559-2009Dixtal Novametrix Neonatal/Pediatric SpO2 Sensor, Foam Wrap Style Catalog #: 6480-25. The SpO2 Foam Wrap Style (Single Patient Use) Sensors are intended to be used to provide for the measurement of the patient's arterial oxygen saturation and pulse rate when connected to Dixtal Medical Pulse Oximeters.Neonatal/Pediatric SPU Sensors may be incorrectly packaged in pouches labeled for Adult/Pediatric SPU Sensors.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain