FDA 510(k)

HERO 642

K-Number: K970649 · 1997-05-16

Decision Date1997-05-16

Product CodeEKS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

HERO 642 is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Mega. It received FDA 510(k) clearance on 1997-05-16 under 510(k) number K970649. The device is classified under product code EKS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERO 642?

HERO 642 is a medical device that received FDA 510(k) clearance on 1997-05-16. The listed applicant is Micro-Mega. The 510(k) number is K970649.

When did HERO 642 receive FDA 510(k) clearance?

HERO 642 received FDA 510(k) clearance on 1997-05-16, under 510(k) number K970649.

Who is the listed applicant for HERO 642?

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

What is the FDA product code for HERO 642?

The FDA product code for HERO 642 is EKS.

Other records listing Micro-Mega 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.

K933639IMKB CONTRA-ANGLES

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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.