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FDA 510(k)

SWEET DREEMS SIMULATOR

K-Number: K860596 · 1986-03-06

ApplicantSweet Dreams, Inc.
Decision Date1986-03-06
Product CodeFMS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SWEET DREEMS SIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Sweet Dreams, Inc.. It received FDA 510(k) clearance on 1986-03-06 under 510(k) number K860596. 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 SWEET DREEMS SIMULATOR?

SWEET DREEMS SIMULATOR is a medical device that received FDA 510(k) clearance on 1986-03-06. The listed applicant is Sweet Dreams, Inc.. The 510(k) number is K860596.

When did SWEET DREEMS SIMULATOR receive FDA 510(k) clearance?

SWEET DREEMS SIMULATOR received FDA 510(k) clearance on 1986-03-06, under 510(k) number K860596.

Who is the listed applicant for SWEET DREEMS SIMULATOR?

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

What is the FDA product code for SWEET DREEMS SIMULATOR?

The FDA product code for SWEET DREEMS SIMULATOR is FMS.

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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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