510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Medtronic Functional Diagnostics A/S

Skovlunde, DK

Medtronic Functional Diagnostics A/S appears in FDA device records in Skovlunde, DK. FDA records list 11 510(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
11
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 11 510(k) clearances for Medtronic Functional Diagnostics A/S between 1999 and 2002. The busiest year on record is 1999, with 4. The most recent is 2002, with 2.

Clearances by year, as a table
510(k) clearance decisions for Medtronic Functional Diagnostics A/S, by decision year
YearClearances
19994
20002
20013
20022
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K014269POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102MYESubstantially Equivalent
K011471BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBERFFXSubstantially Equivalent
K002992DISPOSABLE HYPODERMIC NEEDLE ELECTRODE, MODEL 9013S0421,9013S0431,9013S0441,9013S0451,9013S0461,1013S0421,103S0431IKTSubstantially Equivalent
K011472POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF IDFFXSubstantially Equivalent
K010130POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103FFXSubstantially Equivalent
K000386POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 9043S0111FFXSubstantially Equivalent
K992715NEURO URODYNAMIC SUITE, MODEL 9032E0101FENSubstantially Equivalent
K992713POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS 9043G0121-9043G0151, 9043S0101FFXSubstantially Equivalent
K991389ANORECTAL MANOMETRY SUITE, MODEL 9032S0201FFXSubstantially Equivalent
K990375DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75IKTSubstantially Equivalent
K981733DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111FFXSubstantially 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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Data as of , FDA export datePage updated Source: openFDA, public domain