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FDA 510(k)

DECUBITUS MATTRESS

K-Number: K760963 · 1976-11-18

ApplicantArco Medical Products Co.
Decision Date1976-11-18
Product CodeIKY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DECUBITUS MATTRESS is the device name listed in this FDA 510(k) record. The listed applicant is Arco Medical Products Co.. It received FDA 510(k) clearance on 1976-11-18 under 510(k) number K760963. The device is classified under product code IKY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DECUBITUS MATTRESS?

DECUBITUS MATTRESS is a medical device that received FDA 510(k) clearance on 1976-11-18. The listed applicant is Arco Medical Products Co.. The 510(k) number is K760963.

When did DECUBITUS MATTRESS receive FDA 510(k) clearance?

DECUBITUS MATTRESS received FDA 510(k) clearance on 1976-11-18, under 510(k) number K760963.

Who is the listed applicant for DECUBITUS MATTRESS?

The FDA 510(k) record lists Arco Medical Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DECUBITUS MATTRESS?

The FDA product code for DECUBITUS MATTRESS is IKY.

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Other records listing Arco Medical Products Co. 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.

K802588MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN.K801806EXTERNAL SILASTIC BOOT FOR CARDIAC PULSEK801241UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN.K800837PROGRAMMABLE BIPOLAR CARDIAC GENERATORK800838ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.K800326ARCOLITH 3021-CARDIAC PULSE GENERATOR

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Related Devices (Code: IKY)

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.

K914921SCM-3 AND ACCESSORIESGaymar Industries, Inc.K813226GEL FLOTATION MATTRESSJefferson Industries, Inc.K802833TETRA NATAL-MAT WATER FLOTATION MAT.Tetra Group U.S.A., Inc.K802781BEDDING PADS EGGCREATE PADSLeemart Bedding Mfg. Co.K780779ECONO-FLOAT WATER FLOTATION MATTRESSJefferson Industries, Inc.K772062NEONATAL FLOTATION SYSTEMMedpro, 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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