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FDA 510(k)

BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER

K-Number: K011471 · 2002-11-08

ApplicantMedtronic Functional Diagnostics A/S
Decision Date2002-11-08
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Functional Diagnostics A/S. It received FDA 510(k) clearance on 2002-11-08 under 510(k) number K011471. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER?

BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER is a medical device that received FDA 510(k) clearance on 2002-11-08. The listed applicant is Medtronic Functional Diagnostics A/S. The 510(k) number is K011471.

When did BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER receive FDA 510(k) clearance?

BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER received FDA 510(k) clearance on 2002-11-08, under 510(k) number K011471.

Who is the listed applicant for BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER?

The FDA 510(k) record lists Medtronic Functional Diagnostics A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER?

The FDA product code for BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER is FFX.

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Other records listing Medtronic Functional Diagnostics A/S as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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