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FDA 510(k)

IMAGINE H.E.

K-Number: K012156 · 2001-08-16

ApplicantWieland Edelmetalle GmbH & Co.
Decision Date2001-08-16
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMAGINE H.E. is the device name listed in this FDA 510(k) record. The listed applicant is Wieland Edelmetalle GmbH & Co.. It received FDA 510(k) clearance on 2001-08-16 under 510(k) number K012156. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGINE H.E.?

IMAGINE H.E. is a medical device that received FDA 510(k) clearance on 2001-08-16. The listed applicant is Wieland Edelmetalle GmbH & Co.. The 510(k) number is K012156.

When did IMAGINE H.E. receive FDA 510(k) clearance?

IMAGINE H.E. received FDA 510(k) clearance on 2001-08-16, under 510(k) number K012156.

Who is the listed applicant for IMAGINE H.E.?

The FDA 510(k) record lists Wieland Edelmetalle GmbH & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMAGINE H.E.?

The FDA product code for IMAGINE H.E. is EIH.

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Other records listing Wieland Edelmetalle GmbH & Co. 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.

K020347AGC SPEZIALLEGIERUNGK012839AUROPAL, ORDER-NO.: 2101K012841DUO PAL 6, ORDER-NO.: 2154K012843PORTADUR P 2, MODEL #2031K012827PORTA AURIUM, MODEL 2067K012828PORTA SMK 82, MODEL 2032

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Related Devices (Code: EIH)

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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