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

Calgary, Alberta, CA

Calgary Scientific, Inc. appears in FDA device records in Calgary, Alberta, CA. FDA records list 8 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 8 510(k) clearances for Calgary Scientific, Inc. between 2006 and 2016. The busiest year on record is 2006, with 1. The most recent is 2016, with 1.

Clearances by year, as a table
510(k) clearance decisions for Calgary Scientific, Inc., by decision year
YearClearances
20061
20071
20091
20111
20121
20131
20141
20161
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K161130ResolutionMDLLZSubstantially Equivalent
K133508RESOLUTIONMD MOBILELLZSubstantially Equivalent
K123186RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31LLZSubstantially Equivalent
K120076RESOLUTIONMD WEBLLZSubstantially Equivalent
K111346RESOLUTIONMD MOBILE MODEL RMB-MOB-2XLLZSubstantially Equivalent
K082693RESOLUTIONMD, RELEASE 2.1LLZSubstantially Equivalent
K071086RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0LLZSubstantially Equivalent
K062164RESOLUTIONMD, VERSION 1.3LLZSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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What MDM checks, and what it does not

MDM coverage

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