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FDA 510(k)

ORAL POTENTIAL METER (OPM)

K-Number: K982105 · 1998-09-16

ApplicantPertec of Wisconsin, Inc.
Decision Date1998-09-16
Product CodeLFC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORAL POTENTIAL METER (OPM) is the device name listed in this FDA 510(k) record. The listed applicant is Pertec of Wisconsin, Inc.. It received FDA 510(k) clearance on 1998-09-16 under 510(k) number K982105. The device is classified under product code LFC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORAL POTENTIAL METER (OPM)?

ORAL POTENTIAL METER (OPM) is a medical device that received FDA 510(k) clearance on 1998-09-16. The listed applicant is Pertec of Wisconsin, Inc.. The 510(k) number is K982105.

When did ORAL POTENTIAL METER (OPM) receive FDA 510(k) clearance?

ORAL POTENTIAL METER (OPM) received FDA 510(k) clearance on 1998-09-16, under 510(k) number K982105.

Who is the listed applicant for ORAL POTENTIAL METER (OPM)?

The FDA 510(k) record lists Pertec of Wisconsin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORAL POTENTIAL METER (OPM)?

The FDA product code for ORAL POTENTIAL METER (OPM) is LFC.

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Official Source

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

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