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FDA 510(k)

BABYROCKER

K-Number: K881019 · 1988-06-07

ApplicantCinventa AB
Decision Date1988-06-07
Product CodeFMS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BABYROCKER is the device name listed in this FDA 510(k) record. The listed applicant is Cinventa AB. It received FDA 510(k) clearance on 1988-06-07 under 510(k) number K881019. 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 BABYROCKER?

BABYROCKER is a medical device that received FDA 510(k) clearance on 1988-06-07. The listed applicant is Cinventa AB. The 510(k) number is K881019.

When did BABYROCKER receive FDA 510(k) clearance?

BABYROCKER received FDA 510(k) clearance on 1988-06-07, under 510(k) number K881019.

Who is the listed applicant for BABYROCKER?

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

What is the FDA product code for BABYROCKER?

The FDA product code for BABYROCKER 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.K950059MC INFANT CARE UNIE #PP30Janco Consulting Services

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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