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FDA 510(k)

MULTI

K-Number: K974414 · 1997-12-08

ApplicantMorning Calm Corp.
Decision Date1997-12-08
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MULTI is the device name listed in this FDA 510(k) record. The listed applicant is Morning Calm Corp.. It received FDA 510(k) clearance on 1997-12-08 under 510(k) number K974414. 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 MULTI?

MULTI is a medical device that received FDA 510(k) clearance on 1997-12-08. The listed applicant is Morning Calm Corp.. The 510(k) number is K974414.

When did MULTI receive FDA 510(k) clearance?

MULTI received FDA 510(k) clearance on 1997-12-08, under 510(k) number K974414.

Who is the listed applicant for MULTI?

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

What is the FDA product code for MULTI?

The FDA product code for MULTI is HQY.

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Related PubMed Literature

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.

PMID: 42632356Deployer-side governance of medical imaging artificial intelligence: the regulatory readiness instrument (RRI-MI) for multi-jurisdictional and post-market compliance.International journal of medical informatics ()PMID: 42481192Interventional, multicentre investigation of a novel lumbar total joint replacement: propensity matched study design and protocol.BMJ open ()PMID: 42290427Reliability and Consistency Analysis of Multiple Instruments for Scoliosis Screening in Adolescent Males: A Comparative Study of Instrument Accuracy.Studies in health technology and informatics ()PMID: 41929241A Multidimensional Index Framework for Evaluating the Regulatory Applicability of ISO 10328 Using a Prosthetic Knee Case Study.Medical devices (Auckland, N.Z.) ()

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

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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