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FDA 510(k)

ULTRASCAN DIGITAL B

K-Number: K842757 · 1985-01-09

ApplicantCooperVision, Inc.
Decision Date1985-01-09
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRASCAN DIGITAL B is the device name listed in this FDA 510(k) record. The listed applicant is CooperVision, Inc.. It received FDA 510(k) clearance on 1985-01-09 under 510(k) number K842757. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRASCAN DIGITAL B?

ULTRASCAN DIGITAL B is a medical device that received FDA 510(k) clearance on 1985-01-09. The listed applicant is CooperVision, Inc.. The 510(k) number is K842757.

When did ULTRASCAN DIGITAL B receive FDA 510(k) clearance?

ULTRASCAN DIGITAL B received FDA 510(k) clearance on 1985-01-09, under 510(k) number K842757.

Who is the listed applicant for ULTRASCAN DIGITAL B?

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

What is the FDA product code for ULTRASCAN DIGITAL B?

The FDA product code for ULTRASCAN DIGITAL B is IYO.

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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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