510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Spencer Technologies

Seattle, WA, US

Spencer Technologies appears in FDA device records in Seattle, WA. FDA records list 2 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
0

510(k) clearance history

FDA records hold 2 510(k) clearances for Spencer Technologies between 2000 and 2009. The busiest year on record is 2000, with 1. The most recent is 2009, with 1.

Clearances by year, as a table
510(k) clearance decisions for Spencer Technologies, by decision year
YearClearances
20001
20091
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K092204PMD VIEWERLLZSubstantially Equivalent
K002533TCD 100M, PWD13 TRANSDUCERIYNSubstantially 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-0788-04Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler Ultrasound System & PMD 100 Digital Transcranial Doppler Ultrasound System (these systems are the same hardware and software - the change from TCD 100M to PMD 100 is a marketing change). Software version 1.3.0 Model numbers 10119, 10863, 10919, 10968, 11016, 11052, 11090, 11091, 11235, 11236Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis.Terminated

Verification record

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