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FDA 510(k)

OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)

K-Number: K902954 · 1990-08-23

ApplicantPermobil AB
Decision Date1990-08-23
Product CodeHFC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) is the device name listed in this FDA 510(k) record. The listed applicant is Permobil AB. It received FDA 510(k) clearance on 1990-08-23 under 510(k) number K902954. The device is classified under product code HFC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)?

OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) is a medical device that received FDA 510(k) clearance on 1990-08-23. The listed applicant is Permobil AB. The 510(k) number is K902954.

When did OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) receive FDA 510(k) clearance?

OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) received FDA 510(k) clearance on 1990-08-23, under 510(k) number K902954.

Who is the listed applicant for OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)?

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

What is the FDA product code for OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)?

The FDA product code for OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) is HFC.

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Related Devices (Code: HFC)

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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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