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FDA 510(k)

HERACERAM

K-Number: K002993 · 2000-11-16

ApplicantJ.F. Jelenko & Co., Inc.
Decision Date2000-11-16
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HERACERAM is the device name listed in this FDA 510(k) record. The listed applicant is J.F. Jelenko & Co., Inc.. It received FDA 510(k) clearance on 2000-11-16 under 510(k) number K002993. 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 HERACERAM?

HERACERAM is a medical device that received FDA 510(k) clearance on 2000-11-16. The listed applicant is J.F. Jelenko & Co., Inc.. The 510(k) number is K002993.

When did HERACERAM receive FDA 510(k) clearance?

HERACERAM received FDA 510(k) clearance on 2000-11-16, under 510(k) number K002993.

Who is the listed applicant for HERACERAM?

The FDA 510(k) record lists J.F. Jelenko & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HERACERAM?

The FDA product code for HERACERAM is EIH.

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Other records listing J.F. Jelenko & Co., Inc. 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: 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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