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FDA 510(k)

MOLTENO3

K-Number: K062252 · 2006-09-27

ApplicantIop, Inc.
Decision Date2006-09-27
Product CodeKYF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MOLTENO3 is the device name listed in this FDA 510(k) record. The listed applicant is Iop, Inc.. It received FDA 510(k) clearance on 2006-09-27 under 510(k) number K062252. The device is classified under product code KYF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOLTENO3?

MOLTENO3 is a medical device that received FDA 510(k) clearance on 2006-09-27. The listed applicant is Iop, Inc.. The 510(k) number is K062252.

When did MOLTENO3 receive FDA 510(k) clearance?

MOLTENO3 received FDA 510(k) clearance on 2006-09-27, under 510(k) number K062252.

Who is the listed applicant for MOLTENO3?

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

What is the FDA product code for MOLTENO3?

The FDA product code for MOLTENO3 is KYF.

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Other records listing Iop, 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: KYF)

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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