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FDA 510(k)

SENSILASE PAD 3000

K-Number: K040654 · 2004-06-04

ApplicantOptical Sensors, Inc.
Decision Date2004-06-04
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SENSILASE PAD 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Optical Sensors, Inc.. It received FDA 510(k) clearance on 2004-06-04 under 510(k) number K040654. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSILASE PAD 3000?

SENSILASE PAD 3000 is a medical device that received FDA 510(k) clearance on 2004-06-04. The listed applicant is Optical Sensors, Inc.. The 510(k) number is K040654.

When did SENSILASE PAD 3000 receive FDA 510(k) clearance?

SENSILASE PAD 3000 received FDA 510(k) clearance on 2004-06-04, under 510(k) number K040654.

Who is the listed applicant for SENSILASE PAD 3000?

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

What is the FDA product code for SENSILASE PAD 3000?

The FDA product code for SENSILASE PAD 3000 is DPW.

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Other records listing Optical Sensors, Inc. as applicant

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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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