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FDA 510(k)

ORALSENSOR

K-Number: K953257 · 1996-02-27

ApplicantCycura Corp.
Decision Date1996-02-27
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ORALSENSOR is the device name listed in this FDA 510(k) record. The listed applicant is Cycura Corp.. It received FDA 510(k) clearance on 1996-02-27 under 510(k) number K953257. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORALSENSOR?

ORALSENSOR is a medical device that received FDA 510(k) clearance on 1996-02-27. The listed applicant is Cycura Corp.. The 510(k) number is K953257.

When did ORALSENSOR receive FDA 510(k) clearance?

ORALSENSOR received FDA 510(k) clearance on 1996-02-27, under 510(k) number K953257.

Who is the listed applicant for ORALSENSOR?

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

What is the FDA product code for ORALSENSOR?

The FDA product code for ORALSENSOR is HCC.

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Other records listing Cycura Corp. 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.

K955701NIGHTGUARD DIAGNOSTIC APPLIANCE

Related Devices (Code: HCC)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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