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FDA 510(k)

CEBE

K-Number: K971644 · 1997-06-24

ApplicantSuunto USA
Decision Date1997-06-24
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CEBE is the device name listed in this FDA 510(k) record. The listed applicant is Suunto USA. It received FDA 510(k) clearance on 1997-06-24 under 510(k) number K971644. 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 CEBE?

CEBE is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is Suunto USA. The 510(k) number is K971644.

When did CEBE receive FDA 510(k) clearance?

CEBE received FDA 510(k) clearance on 1997-06-24, under 510(k) number K971644.

Who is the listed applicant for CEBE?

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

What is the FDA product code for CEBE?

The FDA product code for CEBE 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.

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