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FDA 510(k)

BIOSELF 101

K-Number: K823209 · 1983-02-15

ApplicantBioself, Inc.
Decision Date1983-02-15
Product CodeLHD
DecisionSubstantially Equivalent

Device Summary

BIOSELF 101 is the device name listed in this FDA 510(k) record. The listed applicant is Bioself, Inc.. It received FDA 510(k) clearance on 1983-02-15 under 510(k) number K823209. The device is classified under product code LHD. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSELF 101?

BIOSELF 101 is a medical device that received FDA 510(k) clearance on 1983-02-15. The listed applicant is Bioself, Inc.. The 510(k) number is K823209.

When did BIOSELF 101 receive FDA 510(k) clearance?

BIOSELF 101 received FDA 510(k) clearance on 1983-02-15, under 510(k) number K823209.

Who is the listed applicant for BIOSELF 101?

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

What is the FDA product code for BIOSELF 101?

The FDA product code for BIOSELF 101 is LHD.

Related Clinical Trials

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Other records listing Bioself, Inc. 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.

K904211BIOSELF 2000 FERTILITY INDICATORK843699BIOSELF TM 110

Related Devices (Code: LHD)

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.

K200163Ava Fertility TrackerAva AGK122337OVUSENSEFertility Focus, Ltd.K102499DUOFERTILITYCambridge Temperature Concepts , Ltd.K050094LADY COMP USALady Comp USAK030961MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921Microlife Corp.K021978PETIT SOPHIANishitomo Co., 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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