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FDA 510(k)

KAYE SCOOT-ABOUT, MODEL SB1

K-Number: K924848 · 1993-02-12

ApplicantKaye Products, Inc.
Decision Date1993-02-12
Product CodeINM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

KAYE SCOOT-ABOUT, MODEL SB1 is the device name listed in this FDA 510(k) record. The listed applicant is Kaye Products, Inc.. It received FDA 510(k) clearance on 1993-02-12 under 510(k) number K924848. The device is classified under product code INM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAYE SCOOT-ABOUT, MODEL SB1?

KAYE SCOOT-ABOUT, MODEL SB1 is a medical device that received FDA 510(k) clearance on 1993-02-12. The listed applicant is Kaye Products, Inc.. The 510(k) number is K924848.

When did KAYE SCOOT-ABOUT, MODEL SB1 receive FDA 510(k) clearance?

KAYE SCOOT-ABOUT, MODEL SB1 received FDA 510(k) clearance on 1993-02-12, under 510(k) number K924848.

Who is the listed applicant for KAYE SCOOT-ABOUT, MODEL SB1?

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

What is the FDA product code for KAYE SCOOT-ABOUT, MODEL SB1?

The FDA product code for KAYE SCOOT-ABOUT, MODEL SB1 is INM.

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Other records listing Kaye Products, Inc. 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.

K923095KAYE MODEL KIAO PELVIC/THIGH STABILIZERK922061CHAIR, ADJUSTABLE, MECHANICALK885330WHEELCHAIR, MECHANICALK833869CHILD'S WALKERK830466BARS, PARALLEL, EXERCISEK830560EXERCISER, PASSIVE, NON MEASURING

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Related Devices (Code: INM)

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.

K063521NISSIN PEDIATRIC SERIES WHEELCHAIRNissin Medical, Inc.K941738STRYKER 5050 STRECHAIRStryker MedicalK941569CAREMOR CLINERWinco, Inc.K933000RECLINING GERI CHAIRS W/CASTERS & LAP TRAYWinco, Inc.K926028BENCHESTheradapt Products, Inc.K926054ELD-ARONDAK CHAIRAl'S Woodcraft, Inc.

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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