FDA 510(k)

I CARE

K-Number: K941442 · 1994-05-09

Decision Date1994-05-09

Product CodeHQY

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

I CARE is the device name listed in this FDA 510(k) record. The listed applicant is I Care Intl., Inc.. It received FDA 510(k) clearance on 1994-05-09 under 510(k) number K941442. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I CARE?

I CARE is a medical device that received FDA 510(k) clearance on 1994-05-09. The listed applicant is I Care Intl., Inc.. The 510(k) number is K941442.

When did I CARE receive FDA 510(k) clearance?

I CARE received FDA 510(k) clearance on 1994-05-09, under 510(k) number K941442.

Who is the listed applicant for I CARE?

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

What is the FDA product code for I CARE?

The FDA product code for I CARE is HQY.

Related Devices (Code: HQY)

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.

K974852NON-PRESCRIPTION SUNGLASSESChia Hui Spectacles Mfg. Corp.K974860NON-PRESCRIPTION SUNGLASSESWenzhou Ming Ming Optical Co. , Ltd.K974861NON-PRESCRIPTION SUNGLASSESWenzhou Hindar Optical Co., Ltd.K974511SUNGLASSESSun World Intl., Inc.K974441SUNGLASSESHip Shing Fat Co., Ltd.K973528SUNGLASSESJeou Jeou Long Industrial Co., Ltd.

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.