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FDA 510(k)

SPECTRALIS with Flex Module

K-Number: K241163 · 2024-10-11

ApplicantHeidelberg Engineering GmbH
Decision Date2024-10-11
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTRALIS with Flex Module is a medical device manufactured by Heidelberg Engineering GmbH. It received FDA 510(k) clearance on 2024-10-11 under approval number K241163. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRALIS with Flex Module?

SPECTRALIS with Flex Module is a medical device that received FDA 510(k) clearance on 2024-10-11. It is manufactured by Heidelberg Engineering GmbH. The 510(k) number is K241163.

When was SPECTRALIS with Flex Module approved by the FDA?

SPECTRALIS with Flex Module received FDA 510(k) clearance on 2024-10-11, under approval number K241163.

What company makes SPECTRALIS with Flex Module?

SPECTRALIS with Flex Module is manufactured by Heidelberg Engineering GmbH.

What is the FDA product code for SPECTRALIS with Flex Module?

The FDA product code for SPECTRALIS with Flex Module is OBO.

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Related Devices (Code: OBO)

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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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