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FDA 510(k)

CUDDLE HEART -AUDITORY/VIBRATION DEVICE

K-Number: K845002 · 1986-04-23

ApplicantInternational Purchasing Services
Decision Date1986-04-23
Product CodeFMS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CUDDLE HEART -AUDITORY/VIBRATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is International Purchasing Services. It received FDA 510(k) clearance on 1986-04-23 under 510(k) number K845002. The device is classified under product code FMS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUDDLE HEART -AUDITORY/VIBRATION DEVICE?

CUDDLE HEART -AUDITORY/VIBRATION DEVICE is a medical device that received FDA 510(k) clearance on 1986-04-23. The listed applicant is International Purchasing Services. The 510(k) number is K845002.

When did CUDDLE HEART -AUDITORY/VIBRATION DEVICE receive FDA 510(k) clearance?

CUDDLE HEART -AUDITORY/VIBRATION DEVICE received FDA 510(k) clearance on 1986-04-23, under 510(k) number K845002.

Who is the listed applicant for CUDDLE HEART -AUDITORY/VIBRATION DEVICE?

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

What is the FDA product code for CUDDLE HEART -AUDITORY/VIBRATION DEVICE?

The FDA product code for CUDDLE HEART -AUDITORY/VIBRATION DEVICE is FMS.

Related Clinical Trials

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.

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Other records listing International Purchasing Services 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.

K845004CRIB CUDDLE - INFANT BEDK845003CUDDLE CARRIER - INFANT BED

Related Devices (Code: FMS)

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.

K970334NATURE'S CRADLEInfant Advantage, Inc.K963210VAIL 100 PEDIATRIC CRIBVail Products, Inc.K960747NATURE'S CRADLE MODEL C1500Infant Advantage, Inc.K960012STRYKER ADEL BASSINETStryker Corp.K951024NATURE'S CRADLEInfant Advantage, Inc.K950051BREWER COMPANY TEDDY CRIB MODEL 71900-A, B, 71910-A, BThe Brewer Co.

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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