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FDA 510(k)

OLINDA EXM

K-Number: K163687 · 2017-07-19

ApplicantHermes Medical Solutions AB
Decision Date2017-07-19
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OLINDA EXM is the device name listed in this FDA 510(k) record. The listed applicant is Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2017-07-19 under 510(k) number K163687. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLINDA EXM?

OLINDA EXM is a medical device that received FDA 510(k) clearance on 2017-07-19. The listed applicant is Hermes Medical Solutions AB. The 510(k) number is K163687.

When did OLINDA EXM receive FDA 510(k) clearance?

OLINDA EXM received FDA 510(k) clearance on 2017-07-19, under 510(k) number K163687.

Who is the listed applicant for OLINDA EXM?

The FDA 510(k) record lists Hermes Medical Solutions AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLINDA EXM?

The FDA product code for OLINDA EXM is IYX.

Other records listing Hermes Medical Solutions AB 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: IYX)

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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