Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FREEZER TEETHER

K-Number: K002066 · 2000-09-26

ApplicantCool Baby, Inc.
Decision Date2000-09-26
Product CodeKKO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FREEZER TEETHER is the device name listed in this FDA 510(k) record. The listed applicant is Cool Baby, Inc.. It received FDA 510(k) clearance on 2000-09-26 under 510(k) number K002066. The device is classified under product code KKO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREEZER TEETHER?

FREEZER TEETHER is a medical device that received FDA 510(k) clearance on 2000-09-26. The listed applicant is Cool Baby, Inc.. The 510(k) number is K002066.

When did FREEZER TEETHER receive FDA 510(k) clearance?

FREEZER TEETHER received FDA 510(k) clearance on 2000-09-26, under 510(k) number K002066.

Who is the listed applicant for FREEZER TEETHER?

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

What is the FDA product code for FREEZER TEETHER?

The FDA product code for FREEZER TEETHER is KKO.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: KKO)

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.

K123855WATER-FILLED TEETHERSolid Toys Ind. , Ltd.K110615WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLEBebe Toys Manufactory , Ltd.K092025FLUID FILLED TEETHER - GELKids IIK093266MAM COOLERMam International AGK092781MAM TWISTERMam International AGK092494GEL FILLED GUM SOOTHERLuv N' Care, Ltd.

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.

↑