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FDA 510(k)

SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)

K-Number: K113129 · 2011-11-08

ApplicantHeidelberg Engineering GmbH
Decision Date2011-11-08
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) is the device name listed in this FDA 510(k) record. The listed applicant is Heidelberg Engineering GmbH. It received FDA 510(k) clearance on 2011-11-08 under 510(k) number K113129. 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 ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)?

SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) is a medical device that received FDA 510(k) clearance on 2011-11-08. The listed applicant is Heidelberg Engineering GmbH. The 510(k) number is K113129.

When did SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) receive FDA 510(k) clearance?

SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) received FDA 510(k) clearance on 2011-11-08, under 510(k) number K113129.

Who is the listed applicant for SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)?

The FDA 510(k) record lists Heidelberg Engineering GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM)?

The FDA product code for SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) is OBO.

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Other records listing Heidelberg Engineering GmbH 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.

K261019ANTERIONK253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleK250868SPECTRALIS HRA+OCT and variantsK240924AnterionK241163SPECTRALIS with Flex ModuleK240221SPECTRALIS HRA+OCT and variants

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Related Devices (Code: OBO)

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.

K261019ANTERIONHeidelberg Engineering GmbHK253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbHK252633UNITY DX (UDX)Cylite Pty. , Ltd.K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey CorporationK250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbHK240924AnterionHeidelberg Engineering GmbH

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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