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FDA 510(k)

PM 2002 PROLINE/AEC

K-Number: K000163 · 2000-04-18

ApplicantPlanmeca Oy
Decision Date2000-04-18
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PM 2002 PROLINE/AEC is the device name listed in this FDA 510(k) record. The listed applicant is Planmeca Oy. It received FDA 510(k) clearance on 2000-04-18 under 510(k) number K000163. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PM 2002 PROLINE/AEC?

PM 2002 PROLINE/AEC is a medical device that received FDA 510(k) clearance on 2000-04-18. The listed applicant is Planmeca Oy. The 510(k) number is K000163.

When did PM 2002 PROLINE/AEC receive FDA 510(k) clearance?

PM 2002 PROLINE/AEC received FDA 510(k) clearance on 2000-04-18, under 510(k) number K000163.

Who is the listed applicant for PM 2002 PROLINE/AEC?

The FDA 510(k) record lists Planmeca Oy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PM 2002 PROLINE/AEC?

The FDA product code for PM 2002 PROLINE/AEC is EHD.

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Other records listing Planmeca Oy as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: EHD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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