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FDA 510(k)

EBS2605 INFANT HUGGER

K-Number: K892705 · 1989-10-27

ApplicantEquilibrated Bio Systems, Inc.
Decision Date1989-10-27
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EBS2605 INFANT HUGGER is the device name listed in this FDA 510(k) record. The listed applicant is Equilibrated Bio Systems, Inc.. It received FDA 510(k) clearance on 1989-10-27 under 510(k) number K892705. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBS2605 INFANT HUGGER?

EBS2605 INFANT HUGGER is a medical device that received FDA 510(k) clearance on 1989-10-27. The listed applicant is Equilibrated Bio Systems, Inc.. The 510(k) number is K892705.

When did EBS2605 INFANT HUGGER receive FDA 510(k) clearance?

EBS2605 INFANT HUGGER received FDA 510(k) clearance on 1989-10-27, under 510(k) number K892705.

Who is the listed applicant for EBS2605 INFANT HUGGER?

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

What is the FDA product code for EBS2605 INFANT HUGGER?

The FDA product code for EBS2605 INFANT HUGGER is BTY.

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Other records listing Equilibrated Bio Systems, Inc. as applicant

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Related Devices (Code: BTY)

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.

K260242CPETWise PlatformMedibyt , Ltd.K242809Ascent Cardiorespiratory Diagnostic SoftwareMedical Graphics CorporationK223629SpiroSphere, SpiroSphereECG, CardioSphereEresearchtechnology GmbHK231561Pulmonary Function Tester, Model: A9Guangzhou Homesun Medical Technology Co., Ltd.K222982Virtus Metabolic MonitorVirtus Technology ApsK221030Model 9100 PFT/DICOVitalograph Ireland, 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.

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