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FDA 510(k)

BABYCARE

K-Number: K023082 · 2003-03-03

ApplicantBionet Company, Ltd.
Decision Date2003-03-03
Product CodeHEP
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

BABYCARE is the device name listed in this FDA 510(k) record. The listed applicant is Bionet Company, Ltd.. It received FDA 510(k) clearance on 2003-03-03 under 510(k) number K023082. The device is classified under product code HEP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BABYCARE?

BABYCARE is a medical device that received FDA 510(k) clearance on 2003-03-03. The listed applicant is Bionet Company, Ltd.. The 510(k) number is K023082.

When did BABYCARE receive FDA 510(k) clearance?

BABYCARE received FDA 510(k) clearance on 2003-03-03, under 510(k) number K023082.

Who is the listed applicant for BABYCARE?

The FDA 510(k) record lists Bionet Company, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BABYCARE?

The FDA product code for BABYCARE is HEP.

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 Bionet Company, Ltd. 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.

K023034CARDIOTOUCH-3000K011328CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH

Related Devices (Code: HEP)

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.

K101960SONOTRAX SERIES ULTRASONIC POCKET DOPPLEREdan Instruments, Inc.K920353ULTRACELL INSTRUMENT WIPEUltracell Medical Technologies, Inc.K910462POCKET DOP 3Imex Medical Systems, Inc.

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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